Osteoarthritis of the KneeNCT01430559

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

A study testing Meloxicam in people with Osteoarthritis of the Knee, run by Pfizer at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: Meloxicam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 408 participants
Where: 25 sitesChina
Study dates: 24 Oct 2011to 27 Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

China25 sites

China-Japan Friendship Hospital/Rheumatology Department
Beijing, 100029
Peking Union Medical College Hospital
Beijing, 100032
Li Zhanguo
Beijing, 100044
Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
Beijing, 100053
Peking Union Medical College Hospital, Orthopaedics
Beijing, 100730
Department of Orthopedics, West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Department of Rheumatology and Immunology,West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Sichuan Provincial People's Hospital, Rheumatology
Chengdu, Sichuan, 610072
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Anhui Province Hospital
Hefei, Anhui, 230001
QiLu Hospital of Shandong University
Jinan, Shandong, 250012
Liaocheng People's Hospital/Orthopaedics
Liaocheng, Shandong, 252000
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Department of Immunology and Rheumatology, Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Department of Immunology and Rheumatology,Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200001
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Shanghai, 200003
Zhongshan Hospital Fudan University, Rheumatology Department
Shanghai, 200032
The First Affiliated Hospital of Shantou Medical Collage
Shantou, Guangdong, 515041
Rheumatology Department, The First Hospital of China Medical University
Shenyang, Liaoning
Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital
Tianjin, 300052
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, 710032

Other trials in China

About this study

Official title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE

Read the 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

Conditions: Osteoarthritis of the Knee
Being tested: Meloxicam, Placebo
Keywords: Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MeloxicamDrug
Also called Mobic
7.5mg x2 once a day for 12 weeks
PlaceboDrug
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 groups in NCT01430559
Study group	Role	What they receive
Meloxicam	Other	Not described Receives: Drug: Meloxicam
Placebo	Placebo comparator	2 Placebo capsules once a day for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12

Secondary outcomes (9)

Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12
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. Change from baseline was calculated for each WOMAC subscale (pain, stiffness, physical function) and WOMAC average score.
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 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. Change from baseline in two of the WOMAC pain subscale items: pain when walking on a flat surface, and pain when going up or down stairs were calculated.
Measured: Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale 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. WOMAC pain subscale response rates at Week 12 were shown for the reductions from Baseline of greater than (>) 0%, 10% to 90% (in steps of 10%).
Measured: 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
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.
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12
PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 scores with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis.
Measured: Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12
PGAO questionnaire ("Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?") was comprised of 5 grades with 1=very good to 5=very poor, where higher grades indicated more effect of osteoarthritis. The treatment response of an improvement of >=2 points from Baseline in PGAO were summarized.
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12
The SF-36 is a self-administered questionnaire that measures each of the following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: physical component summary (including physical functioning, role-physical, bodily pain and general health) and mental component summary (including vitality, social functioning, role-emotional and mental health). Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status.
Measured: Baseline and Week 12
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12
The EQ-5D is a generic measure of health related quality of life. The EQ-5D has 5 items that assess the level of difficulty (none [score of 1], some/moderate [score of 2], extreme [score of 3]) respondents report for 5 health status domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The change from Baseline (decrease by 2, 1, 0, -1 and -2) at Week 12 in each of the 5 health status domains were summarized.
Measured: Baseline and Week 12
Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12
Daily average knee pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated worse pain. The participants described their pain in the index knee during the past 24 hours by choosing the appropriate number from 0 to 10.
Measured: Baseline, Weeks 2, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201127 Mar 2013

First posted8 Sep 2011 (estimated)
Study start24 Oct 2011
Primary completion27 Mar 2013
Study completion27 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 408 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430559
Sponsor's protocol ID: A9001449
Status last verified: Dec 2020
First submitted: 6 Sep 2011
Last updated: 31 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
ClinicalTrials.gov ID: NCT01430559
Acronym / sponsor ID: A9001449
Conditions: Osteoarthritis of the Knee
Keywords: Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 408 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 24 Oct 2011 (actual)
Primary completion: 27 Mar 2013 (actual)
Study completion: 27 Mar 2013 (actual)
First posted: 8 Sep 2011 (estimated)
Results: Posted 31 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Meloxicam	Other	Drug: Meloxicam
Placebo	Placebo comparator	Drug: Placebo2 Placebo capsules once a day for 12 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MeloxicamAlso: Mobic7.5mg x2 once a day for 12 weeks	Drug	Meloxicam
PlaceboStudy 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.	Drug	Placebo

Primary outcome

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)
Time frame: Screening 1 (Visit 1: Days -21 to -14)
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.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
Time frame: Screening 2 (Visit 2: Days -14 to -10)
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.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
Time frame: Baseline (Day 1)
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.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
Time frame: Visit 8 (Week 12)
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.
Change From Baseline in WOMAC Pain Subscale Scores at Week 12
Time frame: Baseline and 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.

9 secondary outcomes

Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12
Time frame: Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12
Time frame: 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
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12
Time frame: Baseline, Weeks 2, 4, 8 and 12
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12
Time frame: Baseline and Week 12
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12
Time frame: Baseline, Weeks 2, 4, 8 and 12

Results and safety

Results posted to the registry on 31 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	146	126
Meloxicam 15 mg	147	135

Primary outcome: 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)

Time frame: Screening 1 (Visit 1: Days -21 to -14). Mean (Standard Deviation). Unit: units on a scale

Measure	OA Participants n = 356	Healthy Participants n = 52
Pain subscale (paper worksheet)	5.7 (1.47)	–
Stiffness subscale (paper worksheet)	5.3 (1.94)	–
Physical function subscale (paper worksheet)	5.7 (1.56)	–
Total (paper worksheet)	135.9 (35.59)	–
Pain subscale (e-dary)	5.7 (1.47)	0.1 (0.22)
Stiffness subscale (e-diary)	5.3 (2.00)	0.1 (0.31)
Physical function subscale (e-diary)	5.7 (1.56)	0.0 (0.14)
Total (e-diary)	136.0 (35.92)	0.8 (3.66)

Population analysed: Validation Analysis Set (VAS) - all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2); and all enrolled healthy participants. Here, n=number of evaluable participants for each specific category.

Primary outcome: WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary

Time frame: Screening 2 (Visit 2: Days -14 to -10). Mean (Standard Deviation). Unit: units on a scale

Measure	OA Participants n = 356
Pain subscale score	5.6 (1.46)
Stiffness subscale score	5.4 (1.76)
Physical function subscale score	5.8 (1.52)
Total score	136.6 (35.38)

Population analysed: VAS: all OA participants who were non-screen failure at Visit 1 (Screening 1) and returned for Visit 2 (Screening 2).

Primary outcome: WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary

Time frame: Baseline (Day 1). Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 139	Meloxicam 15 mg n = 139
Pain subscale score	6.0 (1.29)	6.0 (1.32)
Stiffness subscale score	5.7 (1.56)	5.6 (1.65)
Physical function subscale score	6.1 (1.32)	6.1 (1.22)
Total score	145.0 (31.05)	144.8 (29.57)

Population analysed: FAS: all randomized participants who received at least 1 dose of study medication, number of participants analyzed=number of participants evaluable for the outcome measure.

Primary outcome: WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary

Time frame: Visit 8 (Week 12). Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 101	Meloxicam 15 mg n = 119
Pain subscale score	4.4 (2.05)	3.6 (1.90)
Stiffness subscale score	4.2 (2.26)	3.5 (1.96)
Physical function subscale score	4.5 (2.08)	3.7 (1.87)
Total score	106.6 (49.70)	88.7 (44.45)

Population analysed: FAS: all randomized participants who received at least 1 dose of study medication, number of participants analyzed=number of participants evaluable for the outcome measure.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 143 (1.4%)	0 of 143 (0%)	Not reported
Meloxicam 15 mg	0 of 144 (0%)	0 of 144 (0%)	Not reported
OA Participants Not Randomized	0 of 63 (0%)	0 of 63 (0%)	Not reported
OA Participants Randomized But Not Treated	0 of 6 (0%)	0 of 6 (0%)	Not reported
Healthy Participants	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Meloxicam in people with Osteoarthritis of the Knee, run by Pfizer at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Screening 1 (Visit 1: Days -21 to -14)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.