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

NCT01430559 | Completed Results

• 1 other identifier: A9001449
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 25

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.

Conditions

Osteoarthritis of the Knee

Keywords

Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12

  Baseline, Weeks 2, 4, 8 and 12

• Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12

  Baseline, Weeks 2, 4, 8 and 12

• Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12

  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

  Baseline, Weeks 2, 4, 8 and 12

• Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12

  Baseline, Weeks 2, 4, 8 and 12

Study Arms (2)

Meloxicam

OTHER

Drug: Meloxicam

Placebo

PLACEBO COMPARATOR

2 Placebo capsules once a day for 12 weeks

Drug: Placebo

Interventions

Meloxicam DRUG

7.5mg x2 once a day for 12 weeks

Also known as: Mobic

Meloxicam

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Anhui Province Hospital

Hefei, Anhui, 230001, China

Location

The Third Affiliated Hospital Of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

The First Affiliated Hospital of Shantou Medical Collage

Shantou, Guangdong, 515041, China

Location

Rheumatology Department, The first Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Rheumatology Department, The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

QiLu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Liaocheng People's Hospital/Orthopaedics

Liaocheng, Shandong, 252000, China

Location

Department of Immunology and Rheumatology, Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

Location

Department of Immunology and Rheumatology,Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

Location

Xijing Hospital, The Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

Department of Orthopedics, West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Department of Rheumatology and Immunology,West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Sichuan Provincial People's Hospital, Rheumatology

Chengdu, Sichuan, 610072, China

Location

China-Japan Friendship Hospital/Rheumatology Department

Beijing, 100029, China

Location

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Li Zhanguo

Beijing, 100044, China

Location

Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University

Beijing, 100053, China

Location

Peking Union Medical College Hospital, Orthopaedics

Beijing, 100730, China

Location

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200001, China

Location

Rheumatology and Immunology Department, Shanghai Changzheng Hospital

Shanghai, 200003, China

Location

Zhongshan Hospital Fudan University, Rheumatology Department

Shanghai, 200032, China

Location

Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Related Links

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

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 8, 2011
• Study Start: October 24, 2011
• Primary Completion: March 27, 2013
• Study Completion: March 27, 2013
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)