A Study of Two Approved Drugs in Patients With Osteoarthr... | NCT00092365

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

NCT00092365

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 9, 2017Actual

Enrollment

413Actual

Phase

Phase 3

Conditions

Osteoarthritis

Interventions

MK0966, rofecoxib
Comparator: celecoxib, placebo

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
2004_071

Status Module

Record Verification Date

May 2017

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

Apr 1, 2003Actual

Primary Completion Date

Nov 1, 2003Actual

Completion Date

Nov 1, 2003Actual

First Submitted Date

Sep 22, 2004

First Submission Date that Met QC Criteria

Sep 24, 2004

First Posted Date

Sep 27, 2004Estimated

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

May 5, 2017

Last Update Posted Date

May 9, 2017Actual

Description Module

Brief Summary

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

Detailed Description

The duration of treatment is 6 weeks.

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

413Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any known allergy to the study drugs

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
16393445	Background	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.

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

Name	Type	Description	Arm Group Labels	Other Names
MK0966, rofecoxib	Drug
Comparator: celecoxib, placebo	Drug