Trial Outcomes & Findings for Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis (NCT NCT01554163)
NCT ID: NCT01554163
Last Updated: 2022-02-09
Results Overview
The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
COMPLETED
PHASE3
239 participants
Baseline, Week 2, Week 6, Week 12
2022-02-09
Participant Flow
Participant milestones
| Measure |
Etoricoxib 30 mg
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
119
|
|
Overall Study
Number Treated
|
119
|
119
|
|
Overall Study
COMPLETED
|
112
|
109
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Etoricoxib 30 mg
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Not Treated
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis
Baseline characteristics by cohort
| Measure |
Etoricoxib 30 mg
n=120 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40 to 50 years
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Customized
51 to 60 years
|
41 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Age, Customized
61 to 70 years
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Age, Customized
71 to 80 years
|
27 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Customized
81 to 90 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation.
The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
|
-21.40 Score on a Scale
Standard Error 1.35
|
-19.76 Score on a Scale
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation.
The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale
|
-17.78 Score on a Scale
Standard Error 1.28
|
-16.46 Score on a Scale
Standard Error 1.28
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation.
The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, "Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing." The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status
|
-24.71 Score on a Scale
Standard Error 1.58
|
-23.61 Score on a Scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: Week 2, Week 6, Week 12Population: The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy.
Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy
|
1.48 Score on a Scale
Standard Error 0.06
|
1.56 Score on a Scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation.
Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status
|
-1.71 Score on a Scale
Standard Error 0.06
|
-1.62 Score on a Scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation.
The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale
|
-18.41 Score on a Scale
Standard Error 1.48
|
-17.55 Score on a Scale
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Week 6, Week 12Population: The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy.
Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 30 mg
n=119 Participants
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 Participants
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy
|
1.39 Score on a Scale
Standard Error 0.07
|
1.49 Score on a Scale
Standard Error 0.07
|
Adverse Events
Etoricoxib 30 mg
Celecoxib 200 mg
Serious adverse events
| Measure |
Etoricoxib 30 mg
n=119 participants at risk
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 participants at risk
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/119 • Up to 12 weeks.
|
0.84%
1/119 • Number of events 1 • Up to 12 weeks.
|
Other adverse events
| Measure |
Etoricoxib 30 mg
n=119 participants at risk
Etoricoxib 30 mg administered orally once daily for 12 weeks.
|
Celecoxib 200 mg
n=119 participants at risk
Celecoxib 200 mg administered orally once daily for 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.1%
12/119 • Number of events 20 • Up to 12 weeks.
|
2.5%
3/119 • Number of events 3 • Up to 12 weeks.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER