Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis (CLOAK)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00643799

First received: March 18, 2008

Last updated: April 22, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

April 22, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00643799 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of health care professional contacts [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Patient's and Physician's Satisfaction with Current Arthritis Therapy [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in WOMAC Total Score from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in WOMAC Subscales from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Response in each WOMAC Subscale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in Medical Outcome Study sleep scale from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Laboratory tests [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
Response in VAS [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in Patient's and Physician's Global Assessment of Pain from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in visual analog scale (VAS) from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Change in Gastrointestinal (GI) Distress Scale from Week 1 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in GI Distress Scale from time of discontinuation of study drug [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Number of hospitalizations, emergency room visits, and procedures [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Change in Work Limitation Questionnaire scale scores from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis

Official Title ^ICMJE

A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-Month Treatment of Subjects With Osteoarthritis of the Knee

Brief Summary

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Drug: Celecoxib
200 mg oral capsule once daily for 6 months
Drug: Naproxen
500 mg oral capsule twice daily for 6 months
Drug: Placebo
Matched oral placebo for 6 months

Study Arm (s)

Experimental: A
Intervention: Drug: Celecoxib
Active Comparator: B
Intervention: Drug: Naproxen
Placebo Comparator: C
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

586

Completion Date

January 2005

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
Functional Capacity Classification of I-III

Exclusion Criteria:

Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
Received acetaminophen within 24 hours of the baseline visit
Acute joint trauma at index joint within the past 3 months with active symptoms
History of gastrointestinal (GI) perforation, obstruction, or bleeding
Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
Received corticosteroids or hyaluronic acid within certain timeframe before study

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00643799

Other Study ID Numbers ^ICMJE

A3191152

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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