Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00640809

Purpose

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

Condition	Intervention	Phase
Bowel Diseases, Inflammatory	Drug: Celecoxib Other: Placebo Drug: Ibuprofen plus Omeprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
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)

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

Drug Information available for: Ibuprofen Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of mucosal breaks in the small bowel for each subject [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	408
Study Start Date:	October 2003
Study Completion Date:	April 2004

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640809

Locations

United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85259
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Los Angeles, California, United States, 90073
Pfizer Investigational Site
LOS ANGELES, California, United States, 90033
United States, Florida
Pfizer Investigational Site
Jupiter, Florida, United States, 33458
Pfizer Investigational Site
Miami, Florida, United States, 33173
United States, Illinois
Pfizer Investigational Site
ROCKFORD, Illinois, United States, 61107
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0362
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-5280

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191071
Study First Received:	March 17, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00640809 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Bowel Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Celecoxib
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Gastrointestinal Agents
Inflammatory Bowel Diseases
Omeprazole
Enzyme Inhibitors
Intestinal Diseases

Pharmacologic Actions
Digestive System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010