Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

NCT ID: NCT00242489

Last Updated: 2022-02-18

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

PHASE2

Total Enrollment

1167 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2002-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.

Detailed Description

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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

Interventions

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MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)

Intervention Type DRUG

Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
* Positive therapeutic effect from prior NSAID therapy.
* Worsening of symptoms upon withdrawal of prior treatment.
* With the exception of OA, in otherwise good health

Exclusion Criteria

* Weight no more than 280 pounds (male or female).
* Recent, sustained use of gastroprotective agents.
* History of arthroscopy of the affected knee within 6 months prior to study entry.
* History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

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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Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ; Protocol 007 Study Group. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford). 2002 Sep;41(9):1052-61. doi: 10.1093/rheumatology/41.9.1052.

Reference Type BACKGROUND
PMID: 12209041 (View on PubMed)

Curtis SP, Bockow B, Fisher C, Olaleye J, Compton A, Ko AT, Reicin AS. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489]. BMC Musculoskelet Disord. 2005 Dec 1;6:58. doi: 10.1186/1471-2474-6-58.

Reference Type RESULT
PMID: 16321158 (View on PubMed)

Other Identifiers

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2005_088

Identifier Type: -

Identifier Source: secondary_id

0663-007

Identifier Type: -

Identifier Source: org_study_id

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