12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543465
First received: October 5, 2007
Last updated: May 15, 2014
Last verified: May 2014

October 5, 2007
May 15, 2014
August 2004
August 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00543465 on ClinicalTrials.gov Archive Site
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12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
Not Provided

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Arthritis, Rheumatoid
  • Osteoarthritis
Drug: MK0782
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00543465
0782-003, 2007_636
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

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