Clinical trial NCT00640809: Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Diseases, Inflammatory
Keywords: Bowel Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of mucosal breaks in the small bowel for each subject
timeFrame: Day 30
Secondary outcomes:
measure: Adverse events
timeFrame: Day 30
measure: Laboratory tests
timeFrame: Day 30
measure: Vital signs
timeFrame: Day 30
measure: Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test
timeFrame: Day 30
measure: Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks
timeFrame: Day 30
measure: Change from screening visit in hemoglobin and hematocrit
timeFrame: Day 30
measure: Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks
timeFrame: Day 30
measure: Physical examination
timeFrame: Day 30
measure: Percentage of subjects with >=1 mucosal breaks
timeFrame: Day 30
measure: Total number of small bowel lesions with or without hemorrhage
timeFrame: Day 30
measure: Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)
timeFrame: Day 30
measure: Change in Patient General Questionnaire Visual Analog Scale from Day 16
timeFrame: Day 30
measure: Change in Severity of Dyspepsia Assessment questionnaire from Day 16
timeFrame: Day 30
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Jupiter
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: