NCT00543465

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
Last Updated

June 2, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

October 5, 2007

Last Update Submit

June 1, 2015

Conditions

Arthritis, RheumatoidOsteoarthritis

Interventions

MK0782DRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 15, 2007

Study Start

August 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

June 2, 2015

Record last verified: 2015-06