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A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
valdecoxib
naproxen
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee, osteoarthritis, hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of < 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing
  • Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age> 50 years old, b. Stiffness < 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing
  • Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"

Exclusion Criteria:

  • Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
WOMAC OA physical function
WOMAC OA pain index
WOMAC OA stiffness index
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Patient's Global Assessment of Arthritis
Physician's Global Assessment of Arthritis

Full Information

First Posted
March 28, 2008
Last Updated
December 3, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00648258
Brief Title
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan
Official Title
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, knee, osteoarthritis, hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
valdecoxib 10 mg tablet by mouth once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
naproxen
Intervention Description
naproxen 500 mg capsule by mouth twice daily for 6 weeks
Primary Outcome Measure Information:
Title
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
Time Frame
Week 2 and Week 6
Title
WOMAC OA physical function
Time Frame
Week 2 and Week 6
Title
WOMAC OA pain index
Time Frame
Week 2 and Week 6
Title
WOMAC OA stiffness index
Time Frame
Week 2 and Week 6
Title
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Time Frame
Week 2
Title
Patient's Global Assessment of Arthritis
Time Frame
Week 2 and Week 6
Title
Physician's Global Assessment of Arthritis
Time Frame
Week 2 and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of < 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age> 50 years old, b. Stiffness < 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor" Exclusion Criteria: Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kweishan
State/Province
Taoyuan
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-141&StudyName=A%20Double-Blind%2C%20Double%20Dummy%2C%20Randomized%20Comparison%20Study%20Of%20The%20Efficacy%20And%20Safety%20Of%20Valdecoxib%2010mg%20QD%20And%20Naproxen%20500mg%20BID%20In%20Treating%20The%20Signs%20And%20Symptoms%20Of%20Osteoarthritis%20Of%20The%20Knee%20Or%20Hip%20In%20Taiwan
Description
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A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

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