Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole
NCT00640809
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
Inclusion criteria:
- Normal, healthy gastrointestinal tract (no small bowel mucosal breaks at Day 14 according to endoscopic data
- No history of GI ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine
- Willing not to drink any alcohol during study period
Exclusion criteria:
- Has established delayed gastric emptying or diabetic gastroparesis
- Has active gastroesophageal reflux disease or requires anti-ulcer medications
- Has taken aspirin or nonsteroidal antinflammatory drugs (ibuprofen, naproxen) more
than 3 times per week within 2 weeks prior to the screening visit; aspirin for
cardiovascular prophylaxis is restricted
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Descriptive Information | ||||
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Brief Title ICMJE | Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole | |||
Official Title ICMJE | Double-Blind, Placebo-Controlled, Randomized Two-Week Study, Comparing Small Bowel Lesions Associated With Celecoxib (200 mg BID) vs. Ibuprofen (800 mg TID) Plus Omeprazole (20 mg QD) | |||
Brief Summary | To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Bowel Diseases, Inflammatory | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Completed | |||
Actual Enrollment ICMJE | 408 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion criteria:
Exclusion Criteria: Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00640809 | |||
Other Study ID Numbers ICMJE | A3191071 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |