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

Primary Purpose

Bowel Diseases, Inflammatory

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Placebo
Ibuprofen plus Omeprazole
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Diseases, Inflammatory focused on measuring Bowel Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Number of mucosal breaks in the small bowel for each subject

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2008
Last Updated
January 29, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00640809
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Diseases, Inflammatory
Keywords
Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
200 mg oral capsule twice daily for 2 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matched placebo for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Ibuprofen plus Omeprazole
Intervention Description
ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
Primary Outcome Measure Information:
Title
Number of mucosal breaks in the small bowel for each subject
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Day 30
Title
Laboratory tests
Time Frame
Day 30
Title
Vital signs
Time Frame
Day 30
Title
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
Title
Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks
Time Frame
Day 30
Title
Change from screening visit in hemoglobin and hematocrit
Time Frame
Day 30
Title
Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks
Time Frame
Day 30
Title
Physical examination
Time Frame
Day 30
Title
Percentage of subjects with >=1 mucosal breaks
Time Frame
Day 30
Title
Total number of small bowel lesions with or without hemorrhage
Time Frame
Day 30
Title
Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)
Time Frame
Day 30
Title
Change in Patient General Questionnaire Visual Analog Scale from Day 16
Time Frame
Day 30
Title
Change in Severity of Dyspepsia Assessment questionnaire from Day 16
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Pfizer Investigational Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0362
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5280
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191071&StudyName=Comparison%20of%20Small%20Bowel%20Lesions%20Associated%20with%20Celecoxib%20versus%20Ibuprofen%20Plus%20Omeprazole
Description
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Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

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