Safety of Celecoxib in Patients With Crohn's Disease

Study Overview
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Brief Summary
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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
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Please refer to brief summary (above).

Official Title
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The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Celebrex
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A Placebo or Celebrex<br>either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks | Drug: Celebrex<br>* 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.<br>* Other names: Celecoxib (brand name);|
| Placebo Comparator: B Placebo or Celebrex<br>either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks | Drug: placebo<br>* placebo PO BID for either the first eight weeks or the last eight weeks of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment | Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment | completion of all study participants | 

Secondary Outcome Measures

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