Safety of Celecoxib in Patients With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00177866
• Other study ID #: 0312013
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 30, 2015
• Start date: December 2003
• Est. completion date: June 2010

Study information

• Verified date: November 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to brief summary (above).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Pfizer, Shadyside Hospital Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment		completion of all study participants	Yes
Secondary	Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores in response to treatment		completion of all study participants	Yes