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A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)

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ClinicalTrials.gov Identifier: NCT00092352
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: MK0966, rofecoxib Drug: Comparator: celecoxib, placebo Phase 3

Detailed Description:
The duration of treatment is 6 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee
Actual Study Start Date : April 29, 2003
Actual Primary Completion Date : December 1, 2003
Actual Study Completion Date : December 1, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib




Primary Outcome Measures :
  1. Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment.

Secondary Outcome Measures :
  1. OA of the knee as measured by PGART over 6 wks of treatment.
  2. WOMAC Question #1 over 6 wks of treatment.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee which requires treatment with medication for pain relief

Exclusion Criteria:

  • Any known allergy to the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092352


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092352     History of Changes
Other Study ID Numbers: 0966-219
2004_070
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents