A Study of Two Approved Drugs in Patients With Osteoarthritis - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092352

Purpose

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	Intervention	Phase
Osteoarthritis	Drug: MK0966, rofecoxib Drug: Comparator: celecoxib, placebo	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Rofecoxib Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

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:

OA of the knee as measured by PGART over 6 wks of treatment.
WOMAC Question #1 over 6 wks of treatment.

Estimated Enrollment:	375
Study Start Date:	May 2003

Detailed Description:

The duration of treatment is 6 weeks.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Birbara C, Ruoff G, Sheldon E, Valenzuela C, Rodgers A, Petruschke RA, Chang DJ, Tershakovec AM. Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies. Curr Med Res Opin. 2006 Jan;22(1):199-210.

Study ID Numbers:	2004_070
Study First Received:	September 22, 2004
Last Updated:	July 5, 2006
ClinicalTrials.gov Identifier:	NCT00092352
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Osteoarthritis, Knee
Celecoxib
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rofecoxib
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009