This study will determine how if MK0782 is safe and tolerable and to determine how often and the severity of stomach and small intestine ulcers develop following administration of MK0782 plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls enteric coated asprin vs placebo. This is an early phase trial and some specific protocol information is in progress...
Date First Received: October 5, 2007
Last Updated: October 12, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 2 | Start Date: July 2004
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
This study will determine how if MK0782 is safe and tolerable and to determine how often and the severity of stomach and small intestine ulcers develop following administration of MK0782 plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls enteric coated asprin vs placebo.
This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0782
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy male or non pregnant female
- 18 years of age or older (age at consent)
- Able to abstain from alcohol, tobacco, spicy foods, limit coffee
- Able to avoid strenuous activity
- Able to read and fill out a study diary
Exclusion Criteria:
- You have participated in an investigational drug study within 4 weeks of entering this study
- Your weight is not within a specific range for the study
- You have a history of GI problems like a gastric ulcer
- You have had gastric or intestinal surgery
- You have had abdominal or chest surgery
- You are currently abusing drugs or alcohol or have a history of abuse
- You have a history of psychiatric disorders
- You are a smoker or have smoked during the last year
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00543868
Study ID Number: 2007_637
ClinicalTrials.gov Identifier: NCT00543868
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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