Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT00720057
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2008-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.', 'otherNumAtRisk': 153, 'otherNumAffected': 10, 'seriousNumAtRisk': 153, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.', 'otherNumAtRisk': 159, 'otherNumAffected': 36, 'seriousNumAtRisk': 159, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Scotoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomach Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tooth Socket Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abscess Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summed Pain Intensity Difference (SPID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'classes': [{'title': 'SPID 0-24', 'categories': [{'measurements': [{'value': '25.9', 'spread': '25.87', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '18.40', 'groupId': 'OG001'}]}]}, {'title': 'SPID16-24', 'categories': [{'measurements': [{'value': '8.8', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '6.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 to 24 hours post dose', 'description': 'Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'classes': [{'title': 'TOTPAR 0 - 6 hours', 'categories': [{'measurements': [{'value': '12.7', 'spread': '7.81', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '5.07', 'groupId': 'OG001'}]}]}, {'title': 'TOTPAR 0 - 12 hours', 'categories': [{'measurements': [{'value': '25.5', 'spread': '17.06', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '10.70', 'groupId': 'OG001'}]}]}, {'title': 'TOTPAR 0 - 16 hours', 'categories': [{'measurements': [{'value': '34.1', 'spread': '23.49', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '14.83', 'groupId': 'OG001'}]}]}, {'title': 'TOTPAR 0 - 24 hours', 'categories': [{'measurements': [{'value': '51.3', 'spread': '36.41', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '23.95', 'groupId': 'OG001'}]}]}, {'title': 'TOTPAR 16 - 24 hours', 'categories': [{'measurements': [{'value': '17.2', 'spread': '13.37', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '9.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-24 hours post dose', 'description': 'Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were based on ITT population (n=312).'}, {'type': 'SECONDARY', 'title': 'Summed Pain Intensity Difference at Specific Time Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'classes': [{'title': 'SPID 0 - 6', 'categories': [{'measurements': [{'value': '6.2', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'SIPD 0 - 12', 'categories': [{'measurements': [{'value': '12.7', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '8.54', 'groupId': 'OG001'}]}]}, {'title': 'SIPD 0 - 16', 'categories': [{'measurements': [{'value': '17.1', 'spread': '16.85', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '11.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-16 hours post dose', 'description': 'Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were based on ITT population (n=312).'}, {'type': 'SECONDARY', 'title': 'Time to First Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.27', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '22.27'}, {'value': '1.90', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '10.12'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'postdose to first use of rescue medication', 'description': 'Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses are based on ITT population (n=312).'}, {'type': 'SECONDARY', 'title': 'Global Assessment of the Investigational Product as a Pain Reliever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at 24 hours postdose or immediately before first use of rescue medication', 'description': 'Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses are based on ITT population (n=312).'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '4.98'}, {'value': '4.13', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '4.75'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours', 'description': 'Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses are based on ITT population (n=312).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The Screening Period occurred up to 28 days prior to the day of dental surgery. A total of 447 subjects were screened, of which 135 were excluded (72 did not meet inclusion criteria, 19 refused to participate, 44 other reasons); 312 subjects were randomized and included in the intent-to-treat (ITT) population for efficacy and safety analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '4.03', 'groupId': 'BG000'}, {'value': '20.4', 'spread': '4.31', 'groupId': 'BG001'}, {'value': '20.6', 'spread': '4.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Pain Intensity by Categorical Scale', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Categorical scale: No Pain (0), Mild Pain (1), Moderate Pain (2), Severe Pain (3).', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Pain Intensity by Visual Analog Scale', 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '13.13', 'groupId': 'BG000'}, {'value': '72.6', 'spread': '11.91', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '12.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Visual Analog Scale 0-100 mm: 0 is no pain and 100 is worse possible pain.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'dispFirstSubmitDate': '2009-12-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2008-07-01', 'dispFirstSubmitQcDate': '2009-12-09', 'resultsFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2008-07-21', 'dispFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-03', 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summed Pain Intensity Difference (SPID)', 'timeFrame': '0 to 24 hours post dose', 'description': 'Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.'}], 'secondaryOutcomes': [{'measure': 'Total Pain Relief (TOTPAR)', 'timeFrame': '0-24 hours post dose', 'description': 'Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.'}, {'measure': 'Summed Pain Intensity Difference at Specific Time Intervals', 'timeFrame': '0-16 hours post dose', 'description': 'Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.'}, {'measure': 'Time to First Use of Rescue Medication', 'timeFrame': 'postdose to first use of rescue medication', 'description': 'Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.'}, {'measure': 'Global Assessment of the Investigational Product as a Pain Reliever', 'timeFrame': 'at 24 hours postdose or immediately before first use of rescue medication', 'description': 'Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).'}, {'measure': 'Time to Onset of Effect', 'timeFrame': 'from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours', 'description': 'Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental Pain', 'Analgesia'], 'conditions': ['Toothache']}, 'referencesModule': {'references': [{'pmid': '26588111', 'type': 'DERIVED', 'citation': 'Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, ambulatory, male and female volunteers between 16 to 45\n* Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction\n* No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain reliever (Over The Counter or prescription), or herbal supplements within 5 days of surgery\n* Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of \\>/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale\n\nExclusion Criteria:\n\n* History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies\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\n* Current or past history of bleeding disorder(s)\n* History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)'}, 'identificationModule': {'nctId': 'NCT00720057', 'briefTitle': 'Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain', 'orgStudyIdInfo': {'id': '13130'}, 'secondaryIdInfos': [{'id': '2014-005269-66', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naproxen sodium ER (BAYH6689)', 'description': 'single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.', 'interventionNames': ['Drug: Naproxen Sodium ER (BAYH6689)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naproxen Sodium ER (BAYH6689)', 'type': 'DRUG', 'description': 'Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery', 'armGroupLabels': ['Naproxen sodium ER (BAYH6689)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84124', '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'}}}}