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

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)

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

Study Overview

• Status: Completed
• Conditions: Bowel Diseases, Inflammatory
• Intervention / Treatment: Drug: Celecoxib; Other: Placebo; Drug: Ibuprofen plus Omeprazole

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Celecoxib; 200 mg oral capsule twice daily 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
Placebo Comparator: B	Other: Placebo; Matched placebo for 2 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 17, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Bowel Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Cyclooxygenase 2 Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Celecoxib; Ibuprofen; Omeprazole
• Other Study ID Numbers: A3191071