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

Study Overview
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Brief Summary
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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
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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

Official Title
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A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Meloxicam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Meloxicam<br> | Drug: Meloxicam<br>* 7.5mg x2 once a day for 12 weeks<br>* Other names: Mobic;|
| Placebo Comparator: Placebo<br>2 Placebo capsules once a day for 12 weeks | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Screening 1 (Visit 1: Days -21 to -14) | 
| 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. | Screening 2 (Visit 2: Days -14 to -10) | 
| 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. | Baseline (Day 1) | 
| 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. | Visit 8 (Week 12) | 
| 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. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Weeks 2, 4, 8 and 12 | 
| 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. | Baseline, Weeks 2, 4, 8 and 12 | 
| 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%). | Baseline and Week 12 | 
| 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. | Baseline, Weeks 2, 4, 8 and 12 | 
| 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. | Baseline, Weeks 2, 4, 8 and 12 | 
| 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. | Baseline, Weeks 2, 4, 8 and 12 | 
| 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. | Baseline and Week 12 | 
| 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. | Baseline and Week 12 | 
| 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. | Baseline, Weeks 2, 4, 8 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee