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Trial record 1 of 1 for:    NCT01430559
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Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01430559
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2011
First Posted Date  ICMJE September 8, 2011
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • 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  ICMJE
  • Meloxicam
    Intervention: Drug: Meloxicam
  • Placebo Comparator: Placebo
    2 Placebo capsules once a day for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
408
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2011)
334
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01430559
Other Study ID Numbers  ICMJE A9001449
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP