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

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Scottsdale, Arizona, 85259 United States
Contact
1-800-718-1021
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

NCT00640809
Pfizer
Completed
Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

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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 SummaryTo evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
Detailed DescriptionNot 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 DateNot 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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