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Safety of Celecoxib in Patients With Crohn's Disease

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Celebrex (Drug); placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
George L Arnold, MD, Principal Investigator, Affiliation: University of Pittsburgh

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.

Clinical Details

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

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

Primary outcome: Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment

Secondary outcome: Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores in response to treatment

Detailed description: Please refer to brief summary (above).

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 2003
Last updated: May 26, 2015

Page last updated: August 20, 2015

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