ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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).
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
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Safety of Celecoxib in Patients With Crohn's Disease | |||
Official Title ICMJE | The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease | |||
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). | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 28 | |||
Original Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00177866 | |||
Other Study ID Numbers ICMJE | 0312013 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Pittsburgh | |||
Study Sponsor ICMJE | University of Pittsburgh | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | University of Pittsburgh | |||
Verification Date | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |