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Trial record 1 of 1 for:    NCT00640809
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Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00640809
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : April 7, 2008
Information provided by:

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 21, 2008
Last Update Posted Date April 7, 2008
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
Number of mucosal breaks in the small bowel for each subject [ Time Frame: Day 30 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00640809 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • Adverse events [ Time Frame: Day 30 ]
  • Laboratory tests [ Time Frame: Day 30 ]
  • Vital signs [ Time Frame: Day 30 ]
  • 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 ]
  • Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks [ Time Frame: Day 30 ]
  • Change from screening visit in hemoglobin and hematocrit [ Time Frame: Day 30 ]
  • Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks [ Time Frame: Day 30 ]
  • Physical examination [ Time Frame: Day 30 ]
  • Percentage of subjects with >=1 mucosal breaks [ Time Frame: Day 30 ]
  • Total number of small bowel lesions with or without hemorrhage [ Time Frame: Day 30 ]
  • Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel) [ Time Frame: Day 30 ]
  • Change in Patient General Questionnaire Visual Analog Scale from Day 16 [ Time Frame: Day 30 ]
  • Change in Severity of Dyspepsia Assessment questionnaire from Day 16 [ Time Frame: Day 30 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
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 Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2008)
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 Call Center Pfizer
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