Trial Outcomes & Findings for Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee (NCT NCT01430559)

Last Updated: 2020-12-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

408 participants

Primary outcome timeframe

Screening 1 (Visit 1: Days -21 to -14)

Results posted on

2020-12-31

Participant Flow

A total of 24 centers in mainland China recruited study participants, starting from 24 Oct 2011 to 14 Dec 2012.

This study comprised of a Screening Period prior to Treatment Period. During Screening, 52 healthy participants and 356 participants with osteoarthritis (OA) were included in validation analysis set (total enrollment=408), 293 out of the 356 OA participants were assigned randomized to treatment, and 6 of these randomized participants did not receive actual treatment.

Participant milestones

Participant milestones
Measure	Placebo Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Meloxicam 15 mg Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Overall Study STARTED	146	147
Overall Study Treated	143	144
Overall Study COMPLETED	126	135
Overall Study NOT COMPLETED	20	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Meloxicam 15 mg Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.
Overall Study Adverse Event	7	3
Overall Study Entry criteria not met	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Medication error	1	0
Overall Study Withdrawal by Subject	3	2
Overall Study Protocol Violation	1	0
Overall Study Other	3	3
Overall Study Randomized, Not Treated	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=143 Participants Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Meloxicam 15 mg n=144 Participants Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.	Total n=287 Participants Total of all reporting groups
Age, Customized 26 to 35 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 36 to 45 years	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized 46 to 55 years	43 Participants n=5 Participants	44 Participants n=7 Participants	87 Participants n=5 Participants
Age, Customized 56 to 65 years	61 Participants n=5 Participants	60 Participants n=7 Participants	121 Participants n=5 Participants
Age, Customized 66 to 75 years	34 Participants n=5 Participants	27 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	122 Participants n=7 Participants	228 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	22 Participants n=7 Participants	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening 1 (Visit 1: Days -21 to -14)

Population: 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.

Outcome measures

Outcome measures
Measure	OA Participants n=356 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=52 Participants Healthy participants who responded to the WOMAC questionnaire.
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) Pain subscale (paper worksheet)	5.7 units on a scale Standard Deviation 1.47	—
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) Stiffness subscale (paper worksheet)	5.3 units on a scale Standard Deviation 1.94	—
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) Physical function subscale (paper worksheet)	5.7 units on a scale Standard Deviation 1.56	—
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) Total (paper worksheet)	135.9 units on a scale Standard Deviation 35.59	—
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) Pain subscale (e-dary)	5.7 units on a scale Standard Deviation 1.47	0.1 units on a scale Standard Deviation 0.22
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) Stiffness subscale (e-diary)	5.3 units on a scale Standard Deviation 2.00	0.1 units on a scale Standard Deviation 0.31
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) Physical function subscale (e-diary)	5.7 units on a scale Standard Deviation 1.56	0.0 units on a scale Standard Deviation 0.14
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) Total (e-diary)	136.0 units on a scale Standard Deviation 35.92	0.8 units on a scale Standard Deviation 3.66

PRIMARY outcome

Timeframe: Screening 2 (Visit 2: Days -14 to -10)

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

Outcome measures

Outcome measures
Measure	OA Participants n=356 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants Healthy participants who responded to the WOMAC questionnaire.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary Pain subscale score	5.6 units on a scale Standard Deviation 1.46	—
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary Stiffness subscale score	5.4 units on a scale Standard Deviation 1.76	—
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary Physical function subscale score	5.8 units on a scale Standard Deviation 1.52	—
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary Total score	136.6 units on a scale Standard Deviation 35.38	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: 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.

Outcome measures

Outcome measures
Measure	OA Participants n=139 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=139 Participants Healthy participants who responded to the WOMAC questionnaire.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary Pain subscale score	6.0 units on a scale Standard Deviation 1.29	6.0 units on a scale Standard Deviation 1.32
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary Stiffness subscale score	5.7 units on a scale Standard Deviation 1.56	5.6 units on a scale Standard Deviation 1.65
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary Physical function subscale score	6.1 units on a scale Standard Deviation 1.32	6.1 units on a scale Standard Deviation 1.22
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary Total score	145.0 units on a scale Standard Deviation 31.05	144.8 units on a scale Standard Deviation 29.57

PRIMARY outcome

Timeframe: Visit 8 (Week 12)

Population: 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.

Outcome measures

Outcome measures
Measure	OA Participants n=101 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=119 Participants Healthy participants who responded to the WOMAC questionnaire.
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary Pain subscale score	4.4 units on a scale Standard Deviation 2.05	3.6 units on a scale Standard Deviation 1.90
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary Stiffness subscale score	4.2 units on a scale Standard Deviation 2.26	3.5 units on a scale Standard Deviation 1.96
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary Physical function subscale score	4.5 units on a scale Standard Deviation 2.08	3.7 units on a scale Standard Deviation 1.87
WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary Total score	106.6 units on a scale Standard Deviation 49.70	88.7 units on a scale Standard Deviation 44.45

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: FAS: all randomized participants who received at least 1 dose of study medication using Baseline Observation Carried Forward (BOCF) imputation method, number of participants analyzed=number of participants evaluable for the outcome measure.

Outcome measures

Outcome measures
Measure	OA Participants n=139 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=139 Participants Healthy participants who responded to the WOMAC questionnaire.
Change From Baseline in WOMAC Pain Subscale Scores at Week 12	-1.24 units on a scale Interval -1.71 to -0.77	-2.06 units on a scale Interval -2.53 to -1.58

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	OA Participants n=139 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=139 Participants Healthy participants who responded to the WOMAC questionnaire.
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Pain subscale (Week 2)	-0.76 units on a scale Interval -1.15 to -0.36	-1.12 units on a scale Interval -1.52 to -0.73
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Pain subscale (Week 4)	-1.18 units on a scale Interval -1.6 to -0.76	-1.53 units on a scale Interval -1.95 to -1.11
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Pain subscale (Week 8)	-1.31 units on a scale Interval -1.74 to -0.87	-1.82 units on a scale Interval -2.26 to -1.39
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Pain subscale (Week 12)	-1.24 units on a scale Interval -1.71 to -0.77	-2.06 units on a scale Interval -2.53 to -1.58
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Stiffness subscale (Week 2)	-0.78 units on a scale Interval -1.16 to -0.39	-1.11 units on a scale Interval -1.49 to -0.72
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Stiffness subscale (Week 4)	-1.14 units on a scale Interval -1.58 to -0.71	-1.34 units on a scale Interval -1.78 to -0.9
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Stiffness subscale (Week 8)	-1.23 units on a scale Interval -1.66 to -0.79	-1.70 units on a scale Interval -2.14 to -1.25
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Stiffness subscale (Week 12)	-1.20 units on a scale Interval -1.67 to -0.72	-1.86 units on a scale Interval -2.34 to -1.39
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Physical function subscale (Week 2)	-0.77 units on a scale Interval -1.19 to -0.36	-1.21 units on a scale Interval -1.63 to -0.8
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Physical function subscale (Week 4)	-1.18 units on a scale Interval -1.62 to -0.75	-1.53 units on a scale Interval -1.96 to -1.09
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Physical function subscale (Week 8)	-1.31 units on a scale Interval -1.74 to -0.88	-1.82 units on a scale Interval -2.26 to -1.38
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Physical function subscale (Week 12)	-1.25 units on a scale Interval -1.73 to -0.77	-2.06 units on a scale Interval -2.54 to -1.58
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Average score (Week 2)	-0.77 units on a scale Interval -1.15 to -0.39	-1.15 units on a scale Interval -1.54 to -0.77
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Average score (Week 4)	-1.17 units on a scale Interval -1.6 to -0.75	-1.47 units on a scale Interval -1.9 to -1.04
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Average score (Week 8)	-1.29 units on a scale Interval -1.71 to -0.86	-1.78 units on a scale Interval -2.22 to -1.35
Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12 Average score (Week 12)	-1.23 units on a scale Interval -1.7 to -0.76	-2.00 units on a scale Interval -2.47 to -1.52

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	OA Participants n=139 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=139 Participants Healthy participants who responded to the WOMAC questionnaire.
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Walking on flat surface (Week 2)	-0.51 units on a scale Interval -0.92 to -0.1	-1.13 units on a scale Interval -1.54 to -0.71
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Walking on flat surface (Week 4)	-1.04 units on a scale Interval -1.5 to -0.59	-1.61 units on a scale Interval -2.07 to -1.15
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Walking on flat surface (Week 8)	-1.17 units on a scale Interval -1.63 to -0.71	-1.87 units on a scale Interval -2.33 to -1.41
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Walking on flat surface (Week 12)	-1.05 units on a scale Interval -1.53 to -0.56	-1.97 units on a scale Interval -2.46 to -1.48
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Going up or down stairs (Week 2)	-1.00 units on a scale Interval -1.4 to -0.6	-1.35 units on a scale Interval -1.75 to -0.94
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Going up or down stairs (Week 4)	-1.34 units on a scale Interval -1.76 to -0.93	-1.74 units on a scale Interval -2.16 to -1.32
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Going up or down stairs (Week 8)	-1.53 units on a scale Interval -2.0 to -1.07	-2.09 units on a scale Interval -2.55 to -1.62
Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12 Going up or down stairs (Week 12)	-1.34 units on a scale Interval -1.83 to -0.86	-2.43 units on a scale Interval -2.91 to -1.94

SECONDARY outcome

Timeframe: 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. 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%).

Outcome measures

Outcome measures
Measure	OA Participants n=139 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=139 Participants Healthy participants who responded to the WOMAC questionnaire.
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=40% reduction	22.4 percentage of participants	43.8 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >0% reduction	53.1 percentage of participants	75.7 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 Greater than or equal to (>=) 10% reduction	46.2 percentage of participants	67.4 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=20% reduction	37.1 percentage of participants	58.3 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=30% reduction	29.4 percentage of participants	49.3 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=50% reduction	16.1 percentage of participants	34.0 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=60% reduction	10.5 percentage of participants	24.3 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=70% reduction	7.7 percentage of participants	12.5 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=80% reduction	4.2 percentage of participants	6.3 percentage of participants
Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12 >=90% reduction	2.1 percentage of participants	3.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 9 participants (4 placebo, 5 meloxicam) who had missing baseline WOMAC data.

Outcome measures

Outcome measures
Measure	OA Participants n=143 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=144 Participants Healthy participants who responded to the WOMAC questionnaire.
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=30% reduction (Week 2)	17.48 percentage of participants	22.92 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=30% reduction (Week 4)	30.07 percentage of participants	36.81 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=30% reduction (Week 8)	34.97 percentage of participants	45.14 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=30% reduction (Week 12)	29.37 percentage of participants	49.31 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=50% reduction (Week 2)	4.90 percentage of participants	9.03 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=50% reduction (Week 4)	9.09 percentage of participants	14.58 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=50% reduction (Week 8)	13.29 percentage of participants	24.31 percentage of participants
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12 >=50% reduction (Week 12)	16.08 percentage of participants	34.03 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	OA Participants n=140 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=139 Participants Healthy participants who responded to the WOMAC questionnaire.
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 Week 2	-0.27 units on a scale Interval -0.39 to -0.15	-0.45 units on a scale Interval -0.57 to -0.33
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 Week 4	-0.37 units on a scale Interval -0.5 to -0.23	-0.53 units on a scale Interval -0.66 to -0.39
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 Week 8	-0.34 units on a scale Interval -0.46 to -0.23	-0.52 units on a scale Interval -0.64 to -0.4
Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12 Week 12	-0.43 units on a scale Interval -0.58 to -0.28	-0.62 units on a scale Interval -0.78 to -0.47

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 8 participants (3 placebo, 5 meloxicam) who had missing baseline PGAO data.

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.

Outcome measures

Outcome measures
Measure	OA Participants n=143 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=144 Participants Healthy participants who responded to the WOMAC questionnaire.
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 Week 2	2.80 percentage of participants	4.86 percentage of participants
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 Week 4	6.29 percentage of participants	11.81 percentage of participants
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 Week 8	5.59 percentage of participants	6.25 percentage of participants
Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12 Week 12	8.39 percentage of participants	13.19 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, n=number of evaluable participants for each specific SF-36 domain.

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.

Outcome measures

Outcome measures
Measure	OA Participants n=143 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=144 Participants Healthy participants who responded to the WOMAC questionnaire.
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 General health	4.60 units on a scale Interval 1.93 to 7.28	5.98 units on a scale Interval 3.29 to 8.67
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Physical functioning	6.95 units on a scale Interval 3.73 to 10.16	12.88 units on a scale Interval 9.65 to 16.12
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Role physical	5.79 units on a scale Interval 1.74 to 9.84	13.95 units on a scale Interval 9.89 to 18.02
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Bodily pain	7.51 units on a scale Interval 4.44 to 10.58	14.87 units on a scale Interval 11.78 to 17.96
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Vitality	5.03 units on a scale Interval 2.56 to 7.5	7.08 units on a scale Interval 4.61 to 9.55
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Social functioning	6.06 units on a scale Interval 2.6 to 9.51	12.02 units on a scale Interval 8.55 to 15.49
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Role emotional	4.65 units on a scale Interval 0.26 to 9.04	10.52 units on a scale Interval 6.11 to 14.93
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Mental health	4.50 units on a scale Interval 2.13 to 6.87	5.07 units on a scale Interval 2.71 to 7.43
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Mental component aggregate	2.19 units on a scale Interval 0.74 to 3.65	3.14 units on a scale Interval 1.67 to 4.6
Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12 Physical component aggregate	2.65 units on a scale Interval 1.36 to 3.94	5.21 units on a scale Interval 3.92 to 6.51

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS: all randomized participants who received at least 1 dose of study medication using BOCF imputation method, number of participants analyzed=number of participants evaluable for the outcome measure, including the 12 participants (5 placebo, 7 meloxicam) who had missing baseline EQ-5D data.

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.

Outcome measures

Outcome measures
Measure	OA Participants n=143 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=144 Participants Healthy participants who responded to the WOMAC questionnaire.
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Usual activities (decrease by 0)	81.1 percentage of participants	63.2 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Usual activities (decrease by -1)	14.7 percentage of participants	29.2 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Mobility (decrease by 2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Mobility (decrease by 1)	2.8 percentage of participants	0.7 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Mobility (decrease by 0)	79.7 percentage of participants	66.0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Mobility (decrease by -1)	14.0 percentage of participants	28.5 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Mobility (decrease by -2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Self-care (decrease by 2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Self-care (decrease by 1)	3.5 percentage of participants	4.2 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Self-care (decrease by 0)	67.8 percentage of participants	55.6 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Self-care (decrease by -1)	25.2 percentage of participants	35.4 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Self-care (decrease by -2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Usual activities (decrease by 2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Usual activities (decrease by 1)	0.7 percentage of participants	2.8 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Usual activities (decrease by -2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Pain/discomfort (decrease by 2)	0 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Pain/discomfort (decrease by 1)	2.1 percentage of participants	2.1 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Pain/discomfort (decrease by 0)	77.6 percentage of participants	67.4 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Pain/discomfort (decrease by -1)	15.4 percentage of participants	25.0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Pain/discomfort (decrease by -2)	1.4 percentage of participants	0.7 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Anxiety/depression (decrease by 2)	0.7 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Anxiety/depression (decrease by 1)	7.7 percentage of participants	6.3 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Anxiety/depression (decrease by 0)	72.0 percentage of participants	67.4 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Anxiety/depression (decrease by -1)	14.7 percentage of participants	20.8 percentage of participants
Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12 Anxiety/depression (decrease by -2)	1.4 percentage of participants	0.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	OA Participants n=141 Participants Participants with OA who responded to the WOMAC questionnaire.	Healthy Participants n=143 Participants Healthy participants who responded to the WOMAC questionnaire.
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 Week 2	-0.67 units on a scale Interval -1.0 to -0.34	-0.97 units on a scale Interval -1.3 to -0.64
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 Week 4	-1.11 units on a scale Interval -1.51 to -0.7	-1.42 units on a scale Interval -1.83 to -1.01
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 Week 8	-1.31 units on a scale Interval -1.78 to -0.85	-1.76 units on a scale Interval -2.22 to -1.29
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 Week 12	-1.43 units on a scale Interval -1.94 to -0.91	-2.06 units on a scale Interval -2.57 to -1.55

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Meloxicam 15 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OA Participants Not Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OA Participants Randomized But Not Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=143 participants at risk Participants were randomized to placebo treatment group at Baseline and received matching placebo (2 capsules once daily) for 12 weeks.	Meloxicam 15 mg n=144 participants at risk Participants were randomized to meloxicam treatment group at Baseline and received meloxicam 7.5 milligram (mg) × 2 once daily for 12 weeks.	OA Participants Not Randomized n=63 participants at risk OA participants in VAS who were not randomized to placebo or meloxicam treatment.	OA Participants Randomized But Not Treated n=6 participants at risk OA participants who were randomized but did not receive actual placebo or meloxicam treatment.	Healthy Participants n=52 participants at risk Healthy participants who were included in validation part of the study.
Investigations White blood cell count decreased	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Red blood cell count decreased	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Angina unstable	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.70% 1/143 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/144 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/63 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER