Clinical trial NCT00177866: Safety of Celecoxib in Patients With Crohn's Disease
Official title: The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Crohn's Disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Shadyside Hospital Foundation
name: Pfizer
First posted: 2005-09-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
timeFrame: completion of all study participants
Secondary outcomes:
measure: Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
timeFrame: completion of all study participants
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: George L Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: