Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-03-09 @ 5:49 AM
Study NCT ID:
NCT01789606
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2012-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety data collected for all participants who received at least 1 dose of study drug(safety population).Same event may appear as AE and SAE.However,distinct events are presented.An event may categorized as serious in 1 participant and as nonserious in other participant,or 1 participant may experience both serious and nonserious event during study.', 'eventGroups': [{'id': 'EG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.', 'otherNumAtRisk': 405, 'otherNumAffected': 163, 'seriousNumAtRisk': 405, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Amenorrhoea', 'notes': 'This is gender specific event. The number of participants evaluable for this event are 223.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Pleural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Selection Arm', 'description': 'Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '63.3', 'upperLimit': '74.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \\>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\\<) 6 hours, if left untreated.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Selection Arm', 'description': 'Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '77.6', 'upperLimit': '87.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \\>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected \'neither\' with a typical pain duration of \\<6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain \\>=6 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Selection Arm', 'description': 'Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '78.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \\<6 hours were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Selection Arm', 'description': 'Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '26.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \\>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Percentage of participants with the use of study medication for \\>10 days with an average daily dose of \\>1600 mg were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Percentage of participants who used the study medication for \\<=10 days and used more than 20 tablets with an average daily dose of \\>1600 mg were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'SECONDARY', 'title': 'Average Daily Dose Among Excessive Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '1821.1', 'spread': '157.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of \\>1600 mg or all participants who used the study medication for \\<=10 days during study period, used more than 20 tablets and had an average daily dose of \\>1600 mg.', 'unitOfMeasure': 'milligram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. 'N' is participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Dosing Days Among Inappropriate Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '8.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \\<6 hours, if left untreated, based on the information provided at the follow up interview.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. 'N' is participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'title': 'Single dose', 'categories': [{'measurements': [{'value': '13.1', 'spread': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'Multiple dose', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \\<6 hours, based on the information provided at the follow up interview.', 'unitOfMeasure': 'pain episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. 'N' is participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '1.188', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.637', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'SECONDARY', 'title': 'Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '4.185', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.', 'unitOfMeasure': 'dosing occasions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'SECONDARY', 'title': 'Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '3.020', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.', 'unitOfMeasure': 'dosing occasions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'SECONDARY', 'title': 'Average Daily Dose of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '781.0', 'spread': '229.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'unitOfMeasure': 'milligram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}, {'type': 'SECONDARY', 'title': 'Maximum Daily Dose of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'classes': [{'categories': [{'measurements': [{'value': '1147.9', 'spread': '604.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 30', 'unitOfMeasure': 'milligram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-Selection Arm', 'description': 'Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.'}, {'id': 'FG001', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '832'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '382'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '450'}]}], 'dropWithdraws': [{'type': 'Participant not Purchased the Product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'No Study Medication Taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Ineligible or not Willing to Continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '348'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '832', 'groupId': 'BG001'}, {'value': '1083', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-Selection Arm', 'description': 'Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication.'}, {'id': 'BG001', 'title': 'Compliance Arm', 'description': 'Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less Than (<)18 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Greater Than or Equal to (>=) 18 years', 'categories': [{'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '827', 'groupId': 'BG001'}, {'value': '1074', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '408', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis population included all the participants who were randomized in the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1083}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2014-07-25', 'completionDateStruct': {'date': '2013-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2012-09-19', 'dispFirstSubmitQcDate': '2014-07-25', 'resultsFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2013-02-08', 'dispFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-24', 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication', 'timeFrame': 'Day 1', 'description': "Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \\>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\\<) 6 hours, if left untreated."}, {'measure': 'Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity', 'timeFrame': 'Day 1', 'description': 'Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \\>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected \'neither\' with a typical pain duration of \\<6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain \\>=6 hours.'}, {'measure': 'Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours', 'timeFrame': 'Day 1', 'description': 'Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \\<6 hours were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours', 'timeFrame': 'Day 1', 'description': "Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \\>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases."}, {'measure': 'Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Percentage of participants with the use of study medication for \\>10 days with an average daily dose of \\>1600 mg were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Percentage of participants who used the study medication for \\<=10 days and used more than 20 tablets with an average daily dose of \\>1600 mg were reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Average Daily Dose Among Excessive Users', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of \\>1600 mg or all participants who used the study medication for \\<=10 days during study period, used more than 20 tablets and had an average daily dose of \\>1600 mg.'}, {'measure': 'Number of Dosing Days Among Inappropriate Users', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \\<6 hours, if left untreated, based on the information provided at the follow up interview.'}, {'measure': 'Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \\<6 hours, based on the information provided at the follow up interview.'}, {'measure': 'Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram', 'timeFrame': 'Day 1 up to Day 30', 'description': 'Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.'}, {'measure': 'Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.'}, {'measure': 'Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.'}, {'measure': 'Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms', 'timeFrame': 'Day 1 up to Day 30', 'description': 'In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.'}, {'measure': 'Average Daily Dose of Study Medication', 'timeFrame': 'Day 1 up to Day 30'}, {'measure': 'Maximum Daily Dose of Study Medication', 'timeFrame': 'Day 1 up to Day 30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Self-selection and actual use/compliance trial.'], 'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '27184785', 'type': 'DERIVED', 'citation': 'Paluch E, Jayawardena S, Wilson B, Farnsworth S. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):397-404. doi: 10.1016/j.japh.2016.03.003. Epub 2016 May 13.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4371008&StudyName=Self-Selection%20and%20Actual%20Use%20Trial%20of%20Ibuprofen%20600%20mg%20Immediate%20Release/Extended%20Caplet', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 12 years of age\n* use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months\n* provide written informed consent (subjects 12-\\<18 years of age provide a written assent and parent/guardian will provide written informed consent)\n* capable of and willing to swallow the study medication\n\nExclusion Criteria:\n\n* participated in other research studies in the last 6 months\n* they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study\n* have a history of known allergies to ibuprofen, aspirin, or other NSAIDs\n* have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days\n* female subjects are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01789606', 'briefTitle': 'Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study', 'orgStudyIdInfo': {'id': 'B4371008'}, 'secondaryIdInfos': [{'id': 'AK-10-11', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen 600 mg Immediate Release/Extended Release Caplet', 'interventionNames': ['Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet']}], 'interventions': [{'name': 'Ibuprofen 600 mg Immediate Release/Extended Release Caplet', 'type': 'DRUG', 'description': 'Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.', 'armGroupLabels': ['Ibuprofen 600 mg Immediate Release/Extended Release Caplet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Medical Arts Rexall Pharmacy', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92886', 'city': 'Yorba Linda', 'state': 'California', 'country': 'United States', 'facility': 'B and B Pharmacy', 'geoPoint': {'lat': 33.88863, 'lon': -117.81311}}, {'zip': '30224', 'city': 'Griffin', 'state': 'Georgia', 'country': 'United States', 'facility': "Wynn's Pharmacy Inc.", 'geoPoint': {'lat': 33.24678, 'lon': -84.26409}}, {'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Stark Pharmacy', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '21228', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Catonsville Pharmacy', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55434', 'city': 'Blaine', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Goodrich Pharmacy', 'geoPoint': {'lat': 45.1608, 'lon': -93.23495}}, {'zip': '55330', 'city': 'Elk River', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Kemper Drug', 'geoPoint': {'lat': 45.30385, 'lon': -93.56718}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Cub Pharmacy Number 1924', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Albers' Medical Pharmacy", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64485', 'city': 'Savannah', 'state': 'Missouri', 'country': 'United States', 'facility': 'Countryside Pharmacy', 'geoPoint': {'lat': 39.94166, 'lon': -94.83025}}, {'zip': '87104', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Duran Central Pharmacy', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87571', 'city': 'Taos', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Total Health and Wellness Center of Taos', 'geoPoint': {'lat': 36.40725, 'lon': -105.57307}}, {'zip': '84401', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'The Medicine Shoppe', 'geoPoint': {'lat': 41.223, 'lon': 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