Safety of Celecoxib in Patients With Crohn's Disease
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Crohn's Disease |
| Intervention | Drug: Celebrex Drug: placebo |
| Phase | Phase 4 |
| Sponsor | University of Pittsburgh |
| Responsible Party | University of Pittsburgh |
| ClinicalTrials.gov Identifier | NCT00177866 |
| First Received | September 13, 2005 |
| Last Updated | December 9, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2005 |
|---|---|
| Last Updated Date | December 9, 2013 |
| Start Date | December 2003 |
| Estimated Primary Completion Date | June 2010 |
| Current Primary Outcome Measures | Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment [Time Frame: completion of all study participants] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores in response to treatment [Time Frame: completion of all study participants] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Safety of Celecoxib in Patients With Crohn's Disease |
|---|---|
| Official Title | The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease |
| Brief Summary | 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. |
| Detailed Description | Please refer to brief summary (above). |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Crohn's Disease |
| Intervention | Drug: Celebrex 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. Other Names: Celecoxib (brand name)Drug: placebo placebo PO BID for either the first eight weeks or the last eight weeks of the study. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 28 |
| Estimated Completion Date | June 2010 |
| Estimated Primary Completion Date | June 2010 |
| Eligibility Criteria | Inclusion Criteria: 1. Greater than 18 years of age or less than 70 years of age 2. Confirmed diagnosis of Crohn's disease 3. Inactive disease (CDAI scores at baseline <150) or active disease (CDAI scores at baseline <200). Exclusion Criteria: 1. Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill [OCP], intrauterine device [IUD], Norplant) 2. Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications 3. NSAID use at time of study 4. Baseline moderate to severe Crohn's disease activity (CDAI > 200) 5. Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran. 6. Treatment with current Crohn's medication for a period of less than 3 months 7. Surgery for Crohn's disease (within 1 month) 8. Known sensitivity to celecoxib, NSAIDs, or sulfonamides 9. History of gastritis, gastrointestinal bleeding, or peptic ulcer disease 10. Advanced kidney disease 11. Severe hepatic impairment 12. Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00177866 |
|---|---|
| Other Study ID Numbers | 0312013 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Pittsburgh |
| Study Sponsor | University of Pittsburgh |
| Collaborators | Shadyside Hospital Foundation Pfizer |
| Investigators | Principal Investigator: George L Arnold, MD University of Pittsburgh |
| Verification Date | December 2013 |