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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00640809
First received: March 17, 2008
Last updated: April 2, 2008
Last verified: March 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
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:
No publications provided

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

Keywords provided by Pfizer:
Bowel Disease

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Ibuprofen
Celecoxib
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014