Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-30 @ 5:15 PM
Study NCT ID:
NCT01495858
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2011-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 2 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs).', 'eventGroups': [{'id': 'EG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally', 'otherNumAtRisk': 107, 'otherNumAffected': 21, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally', 'otherNumAtRisk': 106, 'otherNumAffected': 14, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.', 'otherNumAtRisk': 54, 'otherNumAffected': 17, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wake Time After Sleep Onset (WASO) Measured by Actigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '155.25', 'groupId': 'OG000', 'lowerLimit': '121.57', 'upperLimit': '188.93'}, {'value': '180.08', 'groupId': 'OG001', 'lowerLimit': '146.36', 'upperLimit': '213.80'}, {'value': '364.83', 'groupId': 'OG002', 'lowerLimit': '317.52', 'upperLimit': '412.15'}]}]}], 'analyses': [{'pValue': '0.3047', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 10 hours', 'description': "WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.", 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'PRIMARY', 'title': 'Sleep Latency Measured by Actigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.50', 'groupId': 'OG000', 'lowerLimit': '18.00', 'upperLimit': '28.00'}, {'value': '16.75', 'groupId': 'OG001', 'lowerLimit': '13.50', 'upperLimit': '25.00'}, {'value': '27.50', 'groupId': 'OG002', 'lowerLimit': '16.00', 'upperLimit': '36.50'}]}]}], 'analyses': [{'pValue': '0.1677', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': "Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.", 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'SECONDARY', 'title': 'Total Sleep Time Measured by Actigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '418.66', 'groupId': 'OG000', 'lowerLimit': '385.05', 'upperLimit': '452.28'}, {'value': '392.38', 'groupId': 'OG001', 'lowerLimit': '358.72', 'upperLimit': '426.03'}, {'value': '206.61', 'groupId': 'OG002', 'lowerLimit': '159.39', 'upperLimit': '253.84'}]}]}], 'analyses': [{'pValue': '0.2764', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 10 hours', 'description': "Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.", 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'SECONDARY', 'title': 'Sleep Efficiency Measured by Actigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.777', 'groupId': 'OG000', 'lowerLimit': '64.175', 'upperLimit': '75.380'}, {'value': '65.396', 'groupId': 'OG001', 'lowerLimit': '59.787', 'upperLimit': '71.006'}, {'value': '34.436', 'groupId': 'OG002', 'lowerLimit': '26.566', 'upperLimit': '42.306'}]}]}], 'analyses': [{'pValue': '0.2764', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 10 hours', 'description': "Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.", 'unitOfMeasure': 'Percent of sleep time during in-bed time', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Investigational Product as a Sleep Aid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '0 = Poor', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '1 = Fair', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': '2 = Good', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '3 = Very good', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '4 = Excellent', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = Very poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '2 = Rather poor', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '3 = Neither poor nor good', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '4 = Rather good', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': '5 = Very good', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Calmness of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = Very restless', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '2 = Rather restless', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': '3 = Neither restless nor calm', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '4 = Rather calm', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': '5 = Very calm', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0145', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Easiness to Fall Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = Very difficult', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '2 = Rather difficult', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '3 = Neither difficult nor easy', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': '4 = Rather easy', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': '5 = Very easy', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Premature Awakening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = Woke up much too early', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': '2 = Woke up somewhat too early', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '3 = No', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0387', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Ease of Awakening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = Very difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '2 = Rather difficult', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '3 = Neither difficult nor easy', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '4 = Rather easy', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': '5 = Very easy', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0305', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Well Rested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = Not rested at all', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': '2 = Somewhat unrested', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': '3 = Completely rested', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0176', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Karolinska Sleep Diary - Sufficient Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '1 = No, definitely too little', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': '2 = No, much too little', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '3 = No, somewhat too little', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '4 = Yes, almost enough', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '5 = Yes, definitely enough', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Subjective Sleep Questionnaire - Quality of Your Sleep Last Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '3.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0036', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 hours', 'description': 'Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '2.85', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Subjective Sleep Questionnaire - Time to Fall Asleep Last Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '36.63', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '38.10', 'groupId': 'OG001'}, {'value': '40.0', 'spread': '42.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to Estimate of how long it took to fall asleep (minutes)', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '111.1', 'spread': '121.86', 'groupId': 'OG000'}, {'value': '144.8', 'spread': '125.58', 'groupId': 'OG001'}, {'value': '98.4', 'spread': '89.71', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.50', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4519', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 10 hours', 'description': 'Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'SECONDARY', 'title': 'Overall Rating of Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '0 = No relief', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': '1 = A little relief', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': '2 = Some relief', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '3 = A lot of relief', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '4 = Complete relief', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3707', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'SECONDARY', 'title': 'Time to Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Technically the data is not computable due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Technically the data is not computable due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '146.50', 'groupId': 'OG002', 'lowerLimit': '118.00', 'upperLimit': '314.00'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours', 'description': 'If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population'}, {'type': 'SECONDARY', 'title': 'Cumulative Proportion of Participants Taking Rescue Medication by Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '≤ 60 minutes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '≤ 120 minutes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': '≤ 180 minutes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': '≤ 240 minutes', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': '≤ 300 minutes', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': '≤ 360 minutes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': '≤ 420 minutes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': '≤ 480 minutes', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': '≤ 540 minutes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': '≤ 600 minutes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Investigational Product as a Pain Reliever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'title': '0 = Poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '1 = Fair', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '2 = Good', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '3 = Very good', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '4 = Excellent', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3765', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 hours', 'description': 'The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat) Population with available data (missing values were not imputed)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '13.51', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '11.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 2', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '8.42', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '8.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 2', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '11.94', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '12.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 2', 'unitOfMeasure': 'Beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'OG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.97', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 2', 'unitOfMeasure': 'Breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'FG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'FG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'BG001', 'title': 'Naproxen Sodium 440 mg (BAYH6689)', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.'}, {'id': 'BG002', 'title': 'DPH 50 mg', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'spread': '5.55', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '5.27', 'groupId': 'BG001'}, {'value': '20.8', 'spread': '4.64', 'groupId': 'BG002'}, {'value': '21.2', 'spread': '5.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Categorical Pain Rating Scale', 'classes': [{'title': 'No pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Mild pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Moderate pain', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}, {'title': 'Severe pain', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2012-05-30', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2011-12-16', 'dispFirstSubmitQcDate': '2012-05-30', 'resultsFirstSubmitDate': '2014-01-24', 'studyFirstSubmitQcDate': '2011-12-19', 'dispFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2', 'timeFrame': 'Baseline and day 2'}, {'measure': 'Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2', 'timeFrame': 'Baseline and Day 2'}, {'measure': 'Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2', 'timeFrame': 'Baseline and day 2'}, {'measure': 'Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2', 'timeFrame': 'Baseline and day 2'}], 'primaryOutcomes': [{'measure': 'Wake Time After Sleep Onset (WASO) Measured by Actigraphy', 'timeFrame': 'Up to 10 hours', 'description': "WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects."}, {'measure': 'Sleep Latency Measured by Actigraphy', 'timeFrame': 'Up to 10 hours', 'description': "Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects."}], 'secondaryOutcomes': [{'measure': 'Total Sleep Time Measured by Actigraphy', 'timeFrame': 'Up to 10 hours', 'description': "Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects."}, {'measure': 'Sleep Efficiency Measured by Actigraphy', 'timeFrame': 'Up to 10 hours', 'description': "Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects."}, {'measure': 'Global Assessment of Investigational Product as a Sleep Aid', 'timeFrame': 'Up to 10 hours', 'description': 'The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).'}, {'measure': 'Karolinska Sleep Diary - Sleep Quality', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)'}, {'measure': 'Karolinska Sleep Diary - Calmness of Sleep', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)'}, {'measure': 'Karolinska Sleep Diary - Easiness to Fall Asleep', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)'}, {'measure': 'Karolinska Sleep Diary - Premature Awakening', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)'}, {'measure': 'Karolinska Sleep Diary - Ease of Awakening', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)'}, {'measure': 'Karolinska Sleep Diary - Well Rested', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)'}, {'measure': 'Karolinska Sleep Diary - Sufficient Sleep', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)'}, {'measure': 'Subjective Sleep Questionnaire - Quality of Your Sleep Last Night', 'timeFrame': 'Up to 10 hours', 'description': 'Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent.'}, {'measure': 'Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)'}, {'measure': 'Subjective Sleep Questionnaire - Time to Fall Asleep Last Night', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to Estimate of how long it took to fall asleep (minutes)'}, {'measure': 'Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed', 'timeFrame': 'Up to 10 hours', 'description': 'Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)'}, {'measure': 'Change From Baseline in Pain Intensity', 'timeFrame': 'Baseline and up to 10 hours', 'description': 'Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain'}, {'measure': 'Overall Rating of Pain Relief', 'timeFrame': 'Up to 10 hours', 'description': 'The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4).'}, {'measure': 'Time to Rescue Medication', 'timeFrame': 'Up to 10 hours', 'description': 'If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded'}, {'measure': 'Cumulative Proportion of Participants Taking Rescue Medication by Hour', 'timeFrame': 'Up to 10 hours', 'description': 'If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded'}, {'measure': 'Global Assessment of Investigational Product as a Pain Reliever', 'timeFrame': 'Up to 10 hours', 'description': 'The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Naproxen sodium', 'Diphenhydramine'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '25996289', 'type': 'DERIVED', 'citation': 'Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, ambulatory, male and female volunteers ages 12 and older\n* Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:\n\n * one full bony impaction\n * two partial bony impactions\n * one full bony impaction and one partial bony impaction\n * one full bony impaction and one soft tissue impaction\n * one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.\n* Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of \\>/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery\n* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.\n\nExclusion Criteria:\n\n* History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products\n* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years\n* Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator\n* Current or past history of bleeding disorder(s)\n* Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator\n* Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months\n* Positive alcohol breathalyzer test and positive urine drug test prior to surgery\n* Females who are pregnant or lactating\n* Chronic or severe sleep problems that do not respond to Over the Counter (OTC) medication and requires a prescription hypnotic or sedative\n* Habitually spends less than 6.5 hours in bed'}, 'identificationModule': {'nctId': 'NCT01495858', 'acronym': 'Morpheus/DPH', 'briefTitle': 'Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep', 'orgStudyIdInfo': {'id': '15881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'interventionNames': ['Drug: Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naproxen Sodium 440 mg (BAYH6689)', 'interventionNames': ['Drug: Naproxen Sodium 440 mg (BAYH6689)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DPH 50 mg', 'interventionNames': ['Drug: DPH 50 mg']}], 'interventions': [{'name': 'Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)', 'type': 'DRUG', 'description': 'Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.', 'armGroupLabels': ['Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)']}, {'name': 'Naproxen Sodium 440 mg (BAYH6689)', 'type': 'DRUG', 'description': 'Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.', 'armGroupLabels': ['Naproxen Sodium 440 mg (BAYH6689)']}, {'name': 'DPH 50 mg', 'type': 'DRUG', 'description': 'Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.', 'armGroupLabels': ['DPH 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}