Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED) | NCT00542087

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

NCT00542087

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

516Actual

Phase

Phase 3

Conditions

Osteoarthritis

Interventions

MK0663, etoricoxib / Duration of Treatment: 6 Weeks
Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007_625

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2002Actual

Primary Completion Date

Dec 20, 2002Actual

Completion Date

Dec 20, 2002Actual

First Submitted Date

Oct 5, 2007

First Submission Date that Met QC Criteria

Oct 5, 2007

First Posted Date

Oct 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 15, 2024Actual

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

516Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK0663, etoricoxib / Duration of Treatment: 6 Weeks	Drug
Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

Secondary Outcomes

Measure	Description	Time Frame
The study drug will be safe and well tolerated during the course of the study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14687444	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D000077613	Etoricoxib
D000081206	Duration of Therapy

ID	Term
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines