Safety of Celecoxib in Patients With Crohn's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease|
- 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 ]
- 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 ]
|Study Start Date:||December 2003|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: A Placebo or Celebrex
either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
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 Name: Celecoxib (brand name)
Placebo Comparator: B Placebo or Celebrex
either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks
placebo PO BID for either the first eight weeks or the last eight weeks of the study.
Please refer to brief summary (above).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177866
|Principal Investigator:||George L Arnold, MD||University of Pittsburgh|