Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
Study NCT ID:
NCT00177866
Status:
TERMINATED
Last Update Posted:
2016-08-29
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of Celecoxib in Patients With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Arnoldgl@upmc.edu', 'phone': '412 621-2334', 'title': 'George Arnold, MD', 'organization': 'University of Pittseburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'No results or publication, data destroyed due to age of study.', 'eventGroups': [{'id': 'EG000', 'title': 'Celebrex Followed by Placebo', 'description': 'either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks\n\nCelebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks -', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Followed by Celebrex', 'description': 'Placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celebrex Followed by Placebo', 'description': 'either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks\n\nCelebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks -'}, {'id': 'OG001', 'title': 'Placebo Followed by Celebrex', 'description': 'Placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.'}], 'timeFrame': 'completion of all study participants', 'description': "Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment", 'reportingStatus': 'POSTED', 'populationDescription': 'No results or publication, data destroyed due to age of study.'}, {'type': 'SECONDARY', 'title': 'Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celebrex Followed by Placebo', 'description': 'either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks\n\nCelebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks -'}, {'id': 'OG001', 'title': 'Placebo Followed by Celebrex', 'description': 'Placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.'}], 'timeFrame': 'completion of all study participants', 'description': 'No results or publication, data destroyed due to age of study.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Celebrex Followed by Placebo', 'description': 'either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks\n\nCelebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks -'}, {'id': 'FG001', 'title': 'Placebo Followed by Celebrex', 'description': 'Placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'No results or publication, data destroyed due to age of study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'No results or publication, data destroyed due to age of study.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'No results or publication, data destroyed due to age of study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'No results or publication, data destroyed due to age of study.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'No results or publication, data destroyed due to age of study. Enrollment number retrieved from old IRB database and not from study records and cannot be verified.', 'preAssignmentDetails': 'No results or publication, data destroyed due to age of study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Celebrex Followed by Placebo', 'description': 'either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks\n\nCelebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks -'}, {'id': 'BG001', 'title': 'Placebo Followed by Celebrex', 'description': 'Placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Female'}, {'title': 'Male'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'No results or publication, data destroyed due to age of study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'We were unable to get additional funding to complete study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-15', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment", 'timeFrame': 'completion of all study participants', 'description': "Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment"}], 'secondaryOutcomes': [{'measure': 'Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment', 'timeFrame': 'completion of all study participants', 'description': 'No results or publication, data destroyed due to age of study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': 'The investigators will select 60 people who are 18-70 years of age with Crohn\'s disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigators will monitor the participants for 18 weeks after they start the medication and observe their Crohn\'s disease activity, assessing for flare-ups or exacerbations in the disease and other possible side effects of celecoxib. Based on these observations, a determination will be made by the investigators as to the safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a medication that they can prescribe for people who have Crohn\'s disease and experience chronic pain from arthritis and arthralgia.', 'detailedDescription': 'Please refer to brief summary (above).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Greater than 18 years of age or less than 70 years of age\n2. Confirmed diagnosis of Crohn's disease\n3. Inactive disease (CDAI scores at baseline \\<150) or active disease (CDAI scores at baseline \\<200).\n\nExclusion Criteria:\n\n1. Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill \\[OCP\\], intrauterine device \\[IUD\\], Norplant)\n2. Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications\n3. NSAID use at time of study\n4. Baseline moderate to severe Crohn's disease activity (CDAI \\> 200)\n5. Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran.\n6. Treatment with current Crohn's medication for a period of less than 3 months\n7. Surgery for Crohn's disease (within 1 month)\n8. Known sensitivity to celecoxib, NSAIDs, or sulfonamides\n9. History of gastritis, gastrointestinal bleeding, or peptic ulcer disease\n10. Advanced kidney disease\n11. Severe hepatic impairment\n12. Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin"}, 'identificationModule': {'nctId': 'NCT00177866', 'briefTitle': "Safety of Celecoxib in Patients With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': "The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease", 'orgStudyIdInfo': {'id': '0312013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A Placebo or Celebrex', 'description': 'either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks', 'interventionNames': ['Drug: Celebrex']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B Placebo or Celebrex', 'description': 'either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Celebrex', 'type': 'DRUG', 'otherNames': ['Celecoxib (brand name)'], 'description': 'Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.', 'armGroupLabels': ['A Placebo or Celebrex']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo PO BID for either the first eight weeks or the last eight weeks of the study.', 'armGroupLabels': ['B Placebo or Celebrex']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'George L Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shadyside Hospital Foundation', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}