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A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)

NCT ID: NCT00092365

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-01

Study Completion Date

2003-11-01

Brief Summary

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

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Detailed Description

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The duration of treatment is 6 weeks.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0966, rofecoxib

Intervention Type DRUG

Comparator: celecoxib, placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any known allergy to the study drugs
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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. doi: 10.1185/030079906X80242.

Reference Type BACKGROUND
PMID: 16393445 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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2004_071

Identifier Type: -

Identifier Source: secondary_id

0966-220

Identifier Type: -

Identifier Source: org_study_id

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