Bowel Diseases, Inflammatory Clinical Trial
Official title:
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)
NCT number | NCT00640809 |
Other study ID # | A3191071 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2003 |
Est. completion date | April 2004 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Status | Completed |
Enrollment | 408 |
Est. completion date | April 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 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: 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 |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Ann Arbor | Michigan |
United States | Pfizer Investigational Site | Chicago | Illinois |
United States | Pfizer Investigational Site | Jupiter | Florida |
United States | Pfizer Investigational Site | La Jolla | California |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | Miami | Florida |
United States | Pfizer Investigational Site | Nashville | Tennessee |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | Portland | Oregon |
United States | Pfizer Investigational Site | Rockford | Illinois |
United States | Pfizer Investigational Site | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of mucosal breaks in the small bowel for each subject | Day 30 | ||
Secondary | Adverse events | Day 30 | ||
Secondary | Laboratory tests | Day 30 | ||
Secondary | Vital signs | Day 30 | ||
Secondary | Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test | Day 30 | ||
Secondary | Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks | Day 30 | ||
Secondary | Change from screening visit in hemoglobin and hematocrit | Day 30 | ||
Secondary | Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks | Day 30 | ||
Secondary | Physical examination | Day 30 | ||
Secondary | Percentage of subjects with >=1 mucosal breaks | Day 30 | ||
Secondary | Total number of small bowel lesions with or without hemorrhage | Day 30 | ||
Secondary | Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel) | Day 30 | ||
Secondary | Change in Patient General Questionnaire Visual Analog Scale from Day 16 | Day 30 | ||
Secondary | Change in Severity of Dyspepsia Assessment questionnaire from Day 16 | Day 30 |
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