Safety of Celecoxib in Patients With Crohn’s Disease

Overview

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.

Full Title of Study: “The Safety of Celecoxib (Celebrex) in Patients With Crohn’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2010

Detailed Description

Please refer to brief summary (above).

Interventions

  • 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.
  • Drug: placebo
    • placebo PO BID for either the first eight weeks or the last eight weeks of the study.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Crohn’s Disease Activity Index (CDAI) Scores in Response to Treatment
    • Time Frame: completion of all study participants
    • Change in Crohn’s Disease Activity Index (CDAI) scores in response to treatment

Secondary Measures

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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Collaborator
    • Shadyside Hospital Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • George L Arnold, MD, Principal Investigator, University of Pittsburgh

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