Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

• ClinicalTrials.gov Identifier: NCT00174317
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: December 5, 2006
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: December 5, 2006
• Study Start Date: August 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 9, 2005): Change in patient assessment of arthritis pain on walking VAS (Visual Analog Scale) as measured on a 0-100 mm scale at week 6 compared to baseline
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00174317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 24, 2006)

• Change in patient assessment of arthritis pain on walking VAS (Visual Analog Scale) as measured on a 0-100 mm scale at week 12 compared to baseline.
• Change in patients global assessment of arthritis between treatment groups.

• Original Secondary Outcome Measures (submitted: September 9, 2005): Change in patient assessment of arthritis pain on walking VAS (Visual Analog Scale) as measured on a 0-100 mm scale at week 12 compared to baseline. Change in patient's global assessment of arthritis between treatment groups. Change in physician's global
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip
• Official Title: Clinical Protocol For A Multicentre, Double-Blind, Randomised, Parallel Group Study To Compare The Efficacy and Tolerability Of Celecoxib Vs. Diclofenac In The Treatment Of Subjects With Osteoarthritis Of The Hip Requiring Joint Replacement Therapy
• Brief Summary: To determine if celecoxib 200 mg once daily is as effective as diclofenac 50 mg three times daily in the treatment of pain symptoms associated with osteoarthritis of the hip
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Osteoarthritis, Hip

Intervention

• Drug: Celecoxib
• Drug: Diclofenac

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 9, 2005): 250
• Original Enrollment: Same as current
• Study Completion Date: February 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Diagnosed with osteoarthritis of hip and requiring joint replacement
• Eligible for chronic therapy with an NSAID

Exclusion Criteria:

• Hip surgery anticipated within 8 calendar weeks after first visit
• Active gastrointestinal disease or recent diagnosis of gastrointestinal ulceration (within 60 days of first visit)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00174317
• Other Study ID Numbers: COXA-0508-261
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2005