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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01430559
First received: September 6, 2011
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Osteoarthritis of the Knee
Drug: Meloxicam
Drug: Placebo

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
  • Differences in WOMAC pain subscale scores at Week 12 from baseline between meloxicam and placebo [ Time Frame: At week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All WOMAC subscales (ie, pain, physical function and stiffness), change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo; [ Time Frame: Baselineto week 12 12 ] [ Designated as safety issue: No ]
  • WOMAC pain subscale items, change from baseline to Weeks 2, 4, 8, and 12; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • WOMAC average change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Cumulative distribution of percent change from baseline in the WOMAC pain subscale score to Weeks 2, 4, 8, and 12 between meloxicam and placebo; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • 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; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of OA (PGAO) (5-point Likert scale) change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Treatment response: improvement of greater than or equal to 2 points in PGAO at Weeks 2, 4, 8, and 12; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • SF-36 Health Survey (Appendix 4) change from baseline to Week 12 between meloxicam and placebo; [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • EQ-5D change from baseline to Week 12 between meloxicam and placebo; [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

Enrollment: 353
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Meloxicam Drug: Meloxicam
7.5mg x2 once a day for 12 weeks
Other Name: Mobic
Placebo Comparator: Placebo
2 Placebo capsules once a day for 12 weeks
Drug: Placebo
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430559

Locations
China, Anhui
Pfizer Investigational Site
Hefei, Anhui, China, 230001
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510630
Pfizer Investigational Site
Shantou City, Guangdong, China, 515041
China, Heilongjiang
Pfizer Investigational Site
Harbin, Heilongjiang, China, 150001
China, Hubei
Pfizer Investigational Site
Wuhan, Hubei, China, 430022
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210029
China, Liaoning
Pfizer Investigational Site
Shenyang, Liaoning, China
China, Shandong
Pfizer Investigational Site
Jinan, Shandong, China, 250012
Pfizer Investigational Site
Liaocheng, Shandong, China, 252000
Pfizer Investigational Site
Qingdao, Shandong, China, 266011
China, Shanxi
Pfizer Investigational Site
Xi'an, Shanxi, China, 710032
China, Sichuan
Pfizer Investigational Site
Chengdu, Sichuan, China, 610041
Pfizer Investigational Site
Chengdu, Sichuan, China, 610044
Pfizer Investigational Site
Chengdu, Sichuan, China, 610072
China
Pfizer Investigational Site
Beijing, China, 100044
Pfizer Investigational Site
Beijing, China, 100053
Pfizer Investigational Site
Beijing, China, 100032
Pfizer Investigational Site
Beijing, China, 100730
Pfizer Investigational Site
Beijing, China, 100029
Pfizer Investigational Site
Shanghai, China, 200003
Pfizer Investigational Site
Shanghai, China, 200032
Pfizer Investigational Site
Shanghai, China, 200001
Pfizer Investigational Site
Tianjin, China, 300052
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01430559     History of Changes
Other Study ID Numbers: A9001449
Study First Received: September 6, 2011
Last Updated: June 24, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Pfizer:
Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 02, 2014