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Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Meloxicam
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis of the Knee focused on measuring Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects are required to meet the following criteria to be eligible for Randomization into this study:

  • Male or female Chinese subjects, 18-75 years of age;
  • Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. & Lawrence J, 1957)
  • Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  • History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.
  • Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
  • Signs and symptoms of clinically significant cardiac disease

Sites / Locations

  • Anhui Province Hospital
  • The Third Affiliated Hospital Of Sun Yat-sen University
  • The First Affiliated Hospital of Shantou Medical Collage
  • Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu Province Hospital
  • Rheumatology Department, The First Hospital of China Medical University
  • QiLu Hospital of Shandong University
  • Liaocheng People's Hospital/Orthopaedics
  • Department of Immunology and Rheumatology, Qingdao Municipal Hospital
  • Department of Immunology and Rheumatology,Qingdao Municipal Hospital
  • Xijing Hospital, The Fourth Military Medical University
  • Department of Orthopedics, West China Hospital of Sichuan University
  • Department of Rheumatology and Immunology,West China Hospital of Sichuan University
  • Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital
  • Sichuan Provincial People's Hospital, Rheumatology
  • China-Japan Friendship Hospital/Rheumatology Department
  • Peking Union Medical College Hospital
  • Li Zhanguo
  • Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
  • Peking Union Medical College Hospital, Orthopaedics
  • Renji Hospital Shanghai Jiao Tong University School of Medicine
  • Rheumatology and Immunology Department, Shanghai Changzheng Hospital
  • Zhongshan Hospital Fudan University, Rheumatology Department
  • Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

Meloxicam

Placebo

Arm Description

2 Placebo capsules once a day for 12 weeks

Outcomes

Primary Outcome Measures

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Change From Baseline in WOMAC Pain Subscale Scores at Week 12
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.

Secondary Outcome Measures

Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (>) 0%, 10% to 90% (in steps of 10%).
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12
PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12
PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of >=2 points from Baseline in PGAO were summarized.
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12
The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12
The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none [score of 1], some/moderate [score of 2], extreme [score of 3]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.
Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12
Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.

Full Information

First Posted
September 6, 2011
Last Updated
December 6, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01430559
Brief Title
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Official Title
A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 24, 2011 (Actual)
Primary Completion Date
March 27, 2013 (Actual)
Study Completion Date
March 27, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.
Detailed Description
To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population with osteoarthritis of the knee

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meloxicam
Arm Type
Other
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 Placebo capsules once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Other Intervention Name(s)
Mobic
Intervention Description
7.5mg x2 once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)
Description
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame
Screening 1 (Visit 1: Days -21 to -14)
Title
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
Description
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame
Screening 2 (Visit 2: Days -14 to -10)
Title
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
Description
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame
Baseline (Day 1)
Title
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
Description
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. The WOMAC total score was the sum of scores from the 5, 2 and 17 questions respectively on pain, stiffness and physical function subscales. WOMAC total score ranged from 0 to 240, where higher scores indicated worse health condition.
Time Frame
Visit 8 (Week 12)
Title
Change From Baseline in WOMAC Pain Subscale Scores at Week 12
Description
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12
Description
The WOMAC has 3 subscales: WOMAC pain subscale, WOMAC stiffness subscale and WOMAC physical function subscale, which are comprised of 5, 2 and 17 questions regarding the amount of pain and stiffness experienced in the index knee, and degree of difficulty in doing daily tasks, respectively in the past 48 hours. The WOMAC subscale scores range from 0 to 10 with higher scores indicating higher pain, more stiffness and worse function respectively for pain, stiffness and physical function subscales. The WOMAC subscale scores were calculated as the mean of the scores from the individual questions. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12
Description
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12
Description
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (>) 0%, 10% to 90% (in steps of 10%).
Time Frame
Baseline and Week 12
Title
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12
Description
WOMAC pain subscale is comprised of 5 questions regarding the amount of pain experienced in the index knee in the past 48 hours. The WOMAC pain subscale scores range from 0 to 10 with higher scores indicating higher pain. The WOMAC pain subscale score was calculated as the mean of the scores from the individual questions.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12
Description
PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12
Description
PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of >=2 points from Baseline in PGAO were summarized.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12
Description
The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12
Description
The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none [score of 1], some/moderate [score of 2], extreme [score of 3]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12
Description
Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.
Time Frame
Baseline, Weeks 2, 4, 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects are required to meet the following criteria to be eligible for Randomization into this study: Male or female Chinese subjects, 18-75 years of age; Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. & Lawrence J, 1957) Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee. Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect. Signs and symptoms of clinically significant cardiac disease
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
Anhui Province Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The Third Affiliated Hospital Of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
The First Affiliated Hospital of Shantou Medical Collage
City
Shantou City
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Rheumatology Department, The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
QiLu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Liaocheng People's Hospital/Orthopaedics
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Department of Immunology and Rheumatology, Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Name
Department of Immunology and Rheumatology,Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Name
Xijing Hospital, The Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Department of Orthopedics, West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Department of Rheumatology and Immunology,West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Facility Name
Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Sichuan Provincial People's Hospital, Rheumatology
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
China-Japan Friendship Hospital/Rheumatology Department
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Li Zhanguo
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking Union Medical College Hospital, Orthopaedics
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Zhongshan Hospital Fudan University, Rheumatology Department
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001449&StudyName=Effect%20Of%20Meloxicam%20Versus%20Placebo%20In%20Mainland%20Chinese%20Patients%20With%20Osteoarthritis%20Of%20The%20Knee%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee

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