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TerminatedNCT00543465Updated Jun 2, 2015

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

A Phase 2 interventional study of MK0782 in Arthritis, Rheumatoid and Osteoarthritis, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2015-06-02.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Arthritis, Rheumatoid
  • Osteoarthritis
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 49 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
49 participants (actual)

Interventions

  • DrugMK0782
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00543465
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 15, 2007
Start date
Aug 2004
Primary completion
Nov 2004
Completion
Nov 2004
Last update
Jun 2, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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