Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

Phase 4

Completed

• Conditions: Bowel Diseases, Inflammatory
• Interventions: Other: Placebo; Drug: Celecoxib; Drug: Ibuprofen plus Omeprazole

• Registration Number: NCT00640809
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2004-04
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	-
A	Celecoxib	-
C	Ibuprofen plus Omeprazole	-

Primary Outcome Measures

Name	Time	Method
Number of mucosal breaks in the small bowel for each subject	Day 30

Secondary Outcome Measures

Name	Time	Method
Change in Patient General Questionnaire Visual Analog Scale from Day 16	Day 30
Adverse events	Day 30
Laboratory tests	Day 30
Vital signs	Day 30
Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test	Day 30
Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks	Day 30
Change from screening visit in hemoglobin and hematocrit	Day 30
Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks	Day 30
Physical examination	Day 30
Percentage of subjects with >=1 mucosal breaks	Day 30
Total number of small bowel lesions with or without hemorrhage	Day 30
Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)	Day 30
Change in Severity of Dyspepsia Assessment questionnaire from Day 16	Day 30

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Nashville, Tennessee, United States