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

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NCT00640809

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Study Location
Pfizer Investigational Site
Scottsdale, Arizona, 85259, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammatory Bowel Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Inflammatory Bowel DiseasesComparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole NCT00640809
  1. Scottsdale, Arizona
  2. La Jolla, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Jupiter, Florida
  6. Miami, Florida
  7. Chicago, Illinois
  8. Rockford, Illinois
  9. Ann Arbor, Michigan
  10. New York, New York
  11. Portland, Oregon
  12. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole
Official Title  ICMJE 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)
Brief Summary To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bowel Diseases, Inflammatory
Intervention  ICMJE
  • Drug: Celecoxib
    200 mg oral capsule twice daily for 2 weeks
  • Other: Placebo
    Matched placebo for 2 weeks
  • Drug: Ibuprofen plus Omeprazole
    ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Placebo Comparator: B
    Intervention: Other: Placebo
  • Active Comparator: C
    Intervention: Drug: Ibuprofen plus Omeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2008)		408
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640809
Other Study ID Numbers  ICMJE A3191071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP