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A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

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Organon

Status and phase

Completed
Phase 3

Conditions

Osteoarthritis

Treatments

Drug: MK0663, etoricoxib / Duration of Treatment 12 Weeks
Drug: Placebo or Ibuprofen / Duration of Treatment 12 Weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00269191
0663-071
2005_110

Details and patient eligibility

About

This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Enrollment

528 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
  • Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
  • Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
  • Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.

Exclusion criteria

  • No history of concurrent arthritic disease
  • uncontrolled hypertension or an active cardiac condition
  • No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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