View Clinical Trial (Medical Research Study)

Safety of Celecoxib in Patients With Crohn's Disease - NCT00177866-15232(Clinical Trial 129060)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Pittsburgh
State:  
PA
Zip Code: 15232
Conditions: Crohn's Disease
Purpose: 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.
Study summary: Please refer to brief summary (above).
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
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.