Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

NCT ID: NCT00542087

Last Updated: 2024-08-15

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

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-22

Study Completion Date

2002-12-20

Brief Summary

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To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

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

Participants Investigators

Interventions

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MK0663, etoricoxib / Duration of Treatment: 6 Weeks

Intervention Type DRUG

Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
* Has a history of treatment with NSAIDs with positive therapeutic benefit
* Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
* Females who are able to have children must have negative urine pregnancy tests

Exclusion Criteria

* Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
* History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
* Requires joint replacement
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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Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36. doi: 10.1185/030079903125002469.

Reference Type BACKGROUND
PMID: 14687444 (View on PubMed)

Other Identifiers

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2007_625

Identifier Type: -

Identifier Source: secondary_id

0663-805

Identifier Type: -

Identifier Source: org_study_id

NCT00092794

Identifier Type: -

Identifier Source: nct_alias

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