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

• ClinicalTrials.gov Identifier: NCT01430559
• Recruitment Status: Completed
• First Posted: September 8, 2011
• Last Update Posted: December 4, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: September 6, 2011
• First Posted Date: September 8, 2011
• Last Update Posted Date: December 4, 2018
• Study Start Date: October 2011
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2011)

• 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 ]
• Differences in WOMAC pain subscale scores at Week 12 from baseline between meloxicam and placebo [ Time Frame: At week 12 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2011)

• 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 ]
• WOMAC pain subscale items, change from baseline to Weeks 2, 4, 8, and 12; [ Time Frame: Baseline to week 12 ]
• WOMAC average change from baseline to Weeks 2, 4, 8, and 12 between meloxicam and placebo; [ Time Frame: Baseline to week 12 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• SF-36 Health Survey (Appendix 4) change from baseline to Week 12 between meloxicam and placebo; [ Time Frame: Baseline to week 12 ]
• EQ-5D change from baseline to Week 12 between meloxicam and placebo; [ Time Frame: baseline to week 12 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
• 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
• 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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other
• Condition: Osteoarthritis of the Knee

Intervention

• Drug: Meloxicam
  7.5mg x2 once a day for 12 weeks
  Other Name: Mobic
• 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.

Study Arms

• Meloxicam
  Intervention: Drug: Meloxicam
• Placebo Comparator: Placebo
  2 Placebo capsules once a day for 12 weeks
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2018): 408
• Original Estimated Enrollment (submitted: September 6, 2011): 334
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01430559
• Other Study ID Numbers: A9001449
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2018