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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00640809

Collaborator

(none)

408

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bowel Diseases, Inflammatory	Drug: Celecoxib Other: Placebo Drug: Ibuprofen plus Omeprazole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

408 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: A

Drug: Celecoxib

200 mg oral capsule twice daily for 2 weeks

Placebo Comparator: B

Other: Placebo

Matched placebo for 2 weeks

Active Comparator: C

Drug: Ibuprofen plus Omeprazole

ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks

Outcome Measures

Primary Outcome Measures

Number of mucosal breaks in the small bowel for each subject [Day 30]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Scottsdale	Arizona	United States	85259
2	Pfizer Investigational Site	La Jolla	California	United States	92037
3	Pfizer Investigational Site	Los Angeles	California	United States	90033
4	Pfizer Investigational Site	Los Angeles	California	United States	90073
5	Pfizer Investigational Site	Jupiter	Florida	United States	33458
6	Pfizer Investigational Site	Miami	Florida	United States	33173
7	Pfizer Investigational Site	Chicago	Illinois	United States	60612
8	Pfizer Investigational Site	Rockford	Illinois	United States	61107
9	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48109-0362
10	Pfizer Investigational Site	New York	New York	United States	10021
11	Pfizer Investigational Site	Portland	Oregon	United States	97239
12	Pfizer Investigational Site	Nashville	Tennessee	United States	37232-5280