Safety of Celecoxib in Patients With Crohn's Disease

Phase 4

Terminated

• Conditions: Crohn's Disease
• Interventions: Drug: Celebrex; Drug: placebo

• Registration Number: NCT00177866
• Lead Sponsor: University of Pittsburgh

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 Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2016-06
• Results First Submitted: 2016-06-15
• Results First Submitted QC: 2016-06-15
• Results First Posted: 2016-07-15
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A Placebo or Celebrex	Celebrex	either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
B Placebo or Celebrex	placebo	either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks

Primary Outcome Measures

Name	Time	Method
Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment	completion of all study participants	Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment

Secondary Outcome Measures

Name	Time	Method
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment	completion of all study participants	No results or publication, data destroyed due to age of study.