Conditions: Crohn's Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: no

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).

Arms:
arm 1: either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks arm 2: either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks

Interventions: intervention 1: Celebrex intervention 2: placebo
Intervention descriptions: intervention 1: 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. intervention 2: placebo PO BID for either the first eight weeks or the last eight weeks of the study.

Protocol document: