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

Study Overview
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Brief Summary
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To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole

Official Title
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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)

Conditions
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Bowel Diseases, Inflammatory

Intervention / Treatment
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* Drug: Celecoxib
* Other: Placebo
* Drug: Ibuprofen plus Omeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Celecoxib<br>* 200 mg oral capsule twice daily for 2 weeks<br>|
| Placebo Comparator: B<br> | Other: Placebo<br>* Matched placebo for 2 weeks<br>|
| Active Comparator: C<br> | Drug: Ibuprofen plus Omeprazole<br>* ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mucosal breaks in the small bowel for each subject |  | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Patient General Questionnaire Visual Analog Scale from Day 16 |  | Day 30 | 
| Change in Severity of Dyspepsia Assessment questionnaire from Day 16 |  | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel Disease