Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-28 @ 7:07 AM
Study NCT ID:
NCT01226095
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2010-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of open-label ibuprofen sustained release form.', 'eventGroups': [{'id': 'EG000', 'title': 'Brufen Retard', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.', 'otherNumAtRisk': 519, 'otherNumAffected': 41, 'seriousNumAtRisk': 519, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard Baseline (Visit 1)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '1.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percent of Participant Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}, {'value': '519', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard (Visit 2, Week 2)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}, {'id': 'OG002', 'title': 'Brufen Retard (All Visits)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.39', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '97.71', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '98.55', 'spread': '1.86', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 and 4 weeks', 'description': 'The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).', 'unitOfMeasure': 'percentage of participant compliance', 'reportingStatus': 'POSTED', 'populationDescription': 'Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Joint Tenderness/Stiffness at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}, {'value': '519', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard Baseline (Visit 1)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 2, Week 2)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.'}, {'id': 'OG002', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'title': 'No joint tenderness/stiffness', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}]}, {'title': 'Mild joint tenderness/stiffness', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}]}, {'title': 'Moderate joint tenderness/stiffness', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Severe joint tenderness/stiffness', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks', 'description': 'Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard (Visit 2, Week 2)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '410', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 and 4 weeks', 'description': 'Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard Baseline (Visit 1)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 2, Week 2)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.'}, {'id': 'OG002', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.20', 'spread': '15.68', 'groupId': 'OG000'}, {'value': '13.49', 'spread': '11.67', 'groupId': 'OG001'}, {'value': '7.76', 'spread': '9.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks', 'description': 'The duration of morning stiffness in minutes was assessed at each visit.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, however, only participants with available morning stiffness data were included in the analysis for each visit.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '516', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard (Visit 2, Week 2)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'title': 'Achieved 80% reduction in morning stiffness', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Did not achieve 80% reduction morning stiffness', 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 and 4 weeks', 'description': 'The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for all participants for which data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Ability to Carry Out Normal Activities at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}, {'value': '519', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard Baseline (Visit 1)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.'}, {'id': 'OG001', 'title': 'Brufen Retard (Visit 2, Week 2)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.'}, {'id': 'OG002', 'title': 'Brufen Retard (Visit 3, Week 4)', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}, {'value': '471', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks', 'description': 'The number of participants who were able or unable to carry out normal activities was assessed at each visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brufen Retard', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'classes': [{'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-serious adverse events', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The tolerability population included all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brufen Retard', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '519'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '518'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Poor compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brufen Retard', 'description': 'Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.66', 'spread': '10.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '348', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '519', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 519}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2010-09-07', 'resultsFirstSubmitDate': '2011-11-04', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-16', 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.'}, {'measure': 'Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).', 'timeFrame': '4 weeks', 'description': 'Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.'}], 'secondaryOutcomes': [{'measure': 'Percent of Participant Compliance', 'timeFrame': '2 and 4 weeks', 'description': 'The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).'}, {'measure': 'Number of Participants With Joint Tenderness/Stiffness at Each Visit', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks', 'description': 'Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.'}, {'measure': 'Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).', 'timeFrame': '2 and 4 weeks', 'description': 'Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.'}, {'measure': 'Duration of Morning Stiffness', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks', 'description': 'The duration of morning stiffness in minutes was assessed at each visit.'}, {'measure': 'Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)', 'timeFrame': '2 and 4 weeks', 'description': 'The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.'}, {'measure': 'Number of Participants With the Ability to Carry Out Normal Activities at Each Visit', 'timeFrame': 'Baseline, 2 weeks, and 4 weeks', 'description': 'The number of participants who were able or unable to carry out normal activities was assessed at each visit.'}, {'measure': 'Number of Participants Who Experienced Adverse Events and Serious Adverse Events', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.'}]}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Pain', 'Morning stiffness'], 'conditions': ['Osteoarthritis', 'Pain', 'Morning Stiffness']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, post-marketing observational study to evaluate the effectiveness and compliance of ibuprofen in a sustained release form in the treatment of Egyptian osteoarthritic patients.', 'detailedDescription': 'This was a prospective, longitudinal, multicenter observational study conducted in a clinical practice setting where the study product was used in osteoarthritis patients as indicated in the approved package insert; the dosing regimen of Brufen retard is 2 tablets as a single dose once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients seeking treatment for osteoarthritis and there are clinical or radiological evidence of the disease,\n* Male or female, age ≥ 18\n* Designated to treatment with Ibuprofen in a sustained release form (Brufen Retard) according to the best criterion of the physician and if he decides to treat the patient according to labeled indication and dose for 4 weeks.\n* Patients who have given their written informed consent to participate in the study\n* Patients who are currently taking non steroidal anti inflammatory drugs (NSAIDs), should complete an initial washout phase 10 days depending on the half life of the drug taken\n\nExclusion Criteria:\n\n* Contraindications as described in company core data sheet (CCDS) and specifically\n* Patients with active peptic ulcer\n* Patients who have presented reactions of hypersensitivity (asthma , rhinitis or urticaria ) with ibuprofen or other anti-inflammatory non steroids\n* Patients with active cardiovascular disease and those taking aspirin/warfarin for prophylaxis for myocardial infarction (MI) or stroke\n* Patients with moderate to severe renal diseases\n* Patients with moderate to severe hepatic disease\n* Patients with Crohn's disease\n* Patients included currently in another study\n* Women of childbearing potential must not be pregnant\n* Any patients the investigators consider ineligible for this study"}, 'identificationModule': {'nctId': 'NCT01226095', 'briefTitle': 'Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Prospective, Multi-center, Post-marketing Observational Study to Evaluate the Effectiveness and Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients', 'orgStudyIdInfo': {'id': 'P12-162'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Osteoarthritic patients', 'description': 'Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42584', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42585', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42591', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42593', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42594', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 29755', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42582', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42583', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42586', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42587', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42588', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42589', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42590', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42592', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Reference ID/Investigator# 42595', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Rasha Eldessouky, MBBC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott (Egypt)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clintek', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}