Safety of Celecoxib in Patients With Crohn's Disease
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Celebrex (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
George L Arnold, MD, Principal Investigator, Affiliation: University of Pittsburgh
Overall contact:
Mary R Beaves, BSN, Phone: 412-623-1309, Email: beavesmr@upmc.edu
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Crossover Assignment, Safety Study
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
Mary R Beaves, BSN, Phone: 412-623-1309, Email: beavesmr@upmc.edu
UPMC Shadyside Hospital, Pittsburgh, Pennsylvania 15232, United States; Recruiting
Mary R Beaves, BSN, Phone: 412-623-1309, Email: beavesmr@upmc.edu
George L Arnold, MD, Phone: 412-621-2334, Email: arnoldgl@upmc.edu
George L Arnold, MD, Principal Investigator
Additional Information
Starting date: December 2003
Ending date: July 2010
Last updated: July 7, 2009
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