Comparison of Small Bowel Lesions Associated With Celecoxib NCT00640809

Clinical Trial Details — Status: Completed

To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole

Recruitment information / eligibility
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

Drug:
• Celecoxib
200 mg oral capsule twice daily for 2 weeks

Other:
• Placebo
Matched placebo for 2 weeks

Drug:
• Ibuprofen plus Omeprazole
ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks

Locations
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

Sponsors *(1)*
Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

United States,

Outcome
Type	Measure	Time frame
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

See also
Status	Clinical Trial	Phase
Completed	`NCT04587713` - Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects	Phase 1
Completed	`NCT05043363` - LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19
Completed	`NCT02799615` - Anti-TNF Therapy for Refractory Colitis in Hospitalized Children
Completed	`NCT03408470` - TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects	Phase 1
Not yet recruiting	`NCT02760940` - Anemia in Inflammatory Bowel Disease	Phase 4
Terminated	`NCT04032756` - Tofacitinib Registry of Patients With Ulcerative Colitis in Germany
Terminated	`NCT02255227` - Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD	Phase 2
Completed	`NCT03999294` - Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease	N/A