This study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone. This is an early phase trial and some specific protocol...
Date First Received: October 5, 2007
Last Updated: October 12, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 2 | Start Date: August 2004
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
This study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone.
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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study
- Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition
- Must be willing to limit alcohol use to no more than 2 drinks per day
- Avoid strenuous physical activity
Exclusion Criteria:
- Mentally or legally incapacitated
- Has systemic lupus erythematosus, Paget's disease
- Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying
- Has uncontrolled hypertension
- Has uncontrolled diabetes
- Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months
- Has congestive heart failure
- Has had active liver disease within the last 2 years
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00543465
Study ID Number: 2007_636
ClinicalTrials.gov Identifier: NCT00543465
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
