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

Condition(s) targeted: Osteoarthritis of the Knee

Intervention: Meloxicam (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: A Double-Blind Placebo-Controlled Multicentre Parallel Group Study Of The Effect Of Meloxicam In Mainland Chinese Patients With Osteoarthritis Of The Knee

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome:

WOMAC and the three subscales (pain, stiffness and physical function) at two screenings, baseline and Week 12 to allow the above mentioned validity/reliability/sensitivity analysis

Differences in WOMAC pain subscale scores at Week 12 from baseline between meloxicam and placebo

Secondary outcome:

All WOMAC subscales (ie, pain, physical function and stiffness), change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo;

WOMAC pain subscale items, change from baseline to Weeks 2, 4, 8, and 12;

WOMAC average change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo;

Cumulative distribution of percent change from baseline in the WOMAC pain subscale score to Weeks 2, 4, 8, and 12 between meloxicam and placebo;

Treatment response: reduction in the WOMAC pain subscale of greater than or equal to 30% and greater than or equal to 50% at Weeks 2, 4, 8, and 12 between meloxicam and placebo;

Patient Global Assessment of OA (PGAO) (5-point Likert scale) change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo;

Treatment response: improvement of greater than or equal to 2 points in PGAO at Weeks 2, 4, 8, and 12;

SF-36 Health Survey (Appendix 4) change from baseline to Week 12 between meloxicam and placebo;

EQ-5D change from baseline to Week 12 between meloxicam and placebo;

Average pain score (daily diary) in the index knee change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo by using the 11 point Numeric pain rating scale

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Beijing 100029, China; Active, not recruiting

Pfizer Investigational Site, Beijing 100053, China; Recruiting

Pfizer Investigational Site, Beijing 100032, China; Recruiting

Pfizer Investigational Site, Beijing 100044, China; Recruiting

Pfizer Investigational Site, Beijing 100730, China; Recruiting

Pfizer Investigational Site, Shanghai 200001, China; Active, not recruiting

Pfizer Investigational Site, Shanghai 200003, China; Recruiting

Pfizer Investigational Site, Shanghai 200032, China; Active, not recruiting

Pfizer Investigational Site, Shanghai 200127, China; Not yet recruiting

Pfizer Investigational Site, Tianjin 300052, China; Recruiting

Pfizer Investigational Site, Hefei, Anhui 230001, China; Recruiting

Pfizer Investigational Site, Guangzhou, Guangdong 510630, China; Recruiting

Pfizer Investigational Site, Shantou City, Guangdong 515041, China; Recruiting

Pfizer Investigational Site, Harbin, Heilongjiang 150001, China; Active, not recruiting

Pfizer Investigational Site, Wuhan, Hubei 430022, China; Active, not recruiting

Pfizer Investigational Site, Nanjing, Jiangsu 210029, China; Recruiting

Pfizer Investigational Site, Shenyang, Liaoning, China; Active, not recruiting

Pfizer Investigational Site, Jinan, Shandong 250012, China; Recruiting

Pfizer Investigational Site, Liaocheng, Shandong 252000, China; Recruiting

Pfizer Investigational Site, Qingdao, Shandong 266011, China; Recruiting

Pfizer Investigational Site, Xi'an, Shanxi 710032, China; Active, not recruiting

Pfizer Investigational Site, Chengdu, Sichuan 610041, China; Recruiting

Pfizer Investigational Site, Chengdu, Sichuan 610072, China; Recruiting

Pfizer Investigational Site, Chengdu, Sichuan 610044, China; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2011
Last updated: February 7, 2013