Status:
TERMINATED
Safety of Celecoxib in Patients With Crohn's Disease
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Shadyside Hospital Foundation
Pfizer
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
Detailed Description
Please refer to brief summary (above).
Eligibility Criteria
Inclusion
- Greater than 18 years of age or less than 70 years of age
- Confirmed diagnosis of Crohn's disease
- Inactive disease (CDAI scores at baseline \<150) or active disease (CDAI scores at baseline \<200).
Exclusion
- Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill \[OCP\], intrauterine device \[IUD\], Norplant)
- Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications
- NSAID use at time of study
- Baseline moderate to severe Crohn's disease activity (CDAI \> 200)
- Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran.
- Treatment with current Crohn's medication for a period of less than 3 months
- Surgery for Crohn's disease (within 1 month)
- Known sensitivity to celecoxib, NSAIDs, or sulfonamides
- History of gastritis, gastrointestinal bleeding, or peptic ulcer disease
- Advanced kidney disease
- Severe hepatic impairment
- Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00177866
Start Date
December 1 2003
End Date
June 1 2010
Last Update
August 29 2016
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