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OpenTrials
Completed

NCT Number: NCT00640809

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

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

Completed

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Key information

Conditions

Bowel Diseases, Inflammatory Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

200 mg oral capsule twice daily for 2 weeks

Placebo

Other

Matched placebo for 2 weeks

Ibuprofen plus Omeprazole

Drug

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

Primary outcomes

  1. Number of mucosal breaks in the small bowel for each subject

    Time frame: Day 30

Secondary outcomes

  1. Adverse events

    Time frame: Day 30

  2. Laboratory tests

    Time frame: Day 30

  3. Vital signs

    Time frame: Day 30

  4. 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

  5. Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks

    Time frame: Day 30

  6. Change from screening visit in hemoglobin and hematocrit

    Time frame: Day 30

  7. Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks

    Time frame: Day 30

  8. Physical examination

    Time frame: Day 30

  9. Percentage of subjects with >=1 mucosal breaks

    Time frame: Day 30

  10. Total number of small bowel lesions with or without hemorrhage

    Time frame: Day 30

  11. Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)

    Time frame: Day 30

  12. Change in Patient General Questionnaire Visual Analog Scale from Day 16

    Time frame: Day 30

  13. Change in Severity of Dyspepsia Assessment questionnaire from Day 16

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2003
Study completion
2004
First posted
Mar 21, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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