Trial Outcomes & Findings for Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED) (NCT NCT00264147)
NCT ID: NCT00264147
Last Updated: 2022-02-09
Results Overview
Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
761 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-02-09
Participant Flow
90 multicenter rheumatologists: US (71), Canada (14), Colombia (3), Switzerland (2), recruited 761 study patients from their patient pool and through advertising. First Patient In 04-Jan-2006, Last Patient Last Visit 26-Mar-2008.
Patients must have taken Non Steroidal Anti-inflammatory Drugs (NSAIDs) at a therapeutic labeled dose on a regular basis and demonstrated a clinical response in the past and at screening. Following a protocol-specified "washout," patients must have demonstrated disease activity and worsening in symptoms of Rheumatoid Arthritis from the screening.
Participant milestones
| Measure |
Placebo
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
Treatment I and II: Etoricoxib 90 mg orally once daily
|
Diclofenac 150 mg (Treatment II)
Treatment II: Diclofenac 75 mg orally twice daily
|
|---|---|---|---|---|---|---|
|
Treatment I Period
STARTED
|
161
|
154
|
151
|
140
|
155
|
0
|
|
Treatment I Period
COMPLETED
|
63
|
71
|
74
|
68
|
99
|
0
|
|
Treatment I Period
NOT COMPLETED
|
98
|
83
|
77
|
72
|
56
|
0
|
|
Treatment II Period
STARTED
|
0
|
0
|
0
|
0
|
180
|
149
|
|
Treatment II Period
COMPLETED
|
0
|
0
|
0
|
0
|
147
|
116
|
|
Treatment II Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
33
|
33
|
Reasons for withdrawal
| Measure |
Placebo
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
Treatment I and II: Etoricoxib 90 mg orally once daily
|
Diclofenac 150 mg (Treatment II)
Treatment II: Diclofenac 75 mg orally twice daily
|
|---|---|---|---|---|---|---|
|
Treatment I Period
Adverse Event
|
3
|
6
|
3
|
5
|
7
|
0
|
|
Treatment I Period
Laboratory Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment I Period
Lack of Efficacy
|
6
|
2
|
8
|
0
|
1
|
0
|
|
Treatment I Period
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Treatment I Period
Protocol Violation
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Treatment I Period
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
2
|
0
|
|
Treatment I Period
Patient out of town for an extended time
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment I Period
Unblinded due to Serious Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment I Period
Reassigned to Treatment II Period
|
84
|
72
|
65
|
63
|
45
|
0
|
|
Treatment II Period
Adverse Event
|
0
|
0
|
0
|
0
|
9
|
9
|
|
Treatment II Period
Laboratory Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment II Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
20
|
19
|
|
Treatment II Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Treatment II Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Treatment II Period
Pre-scheduled total hip replacement
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Placebo
n=161 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=154 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=151 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=140 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=155 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
Total
n=761 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 11.80 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 11.92 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.96 • n=4 Participants
|
54.9 years
STANDARD_DEVIATION 12.54 • n=21 Participants
|
57.0 years
STANDARD_DEVIATION 11.75 • n=10 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
613 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
148 Participants
n=10 Participants
|
|
American Rheumatism Association Functional Class
Class I
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
221 Participants
n=10 Participants
|
|
American Rheumatism Association Functional Class
Class II
|
102 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
439 Participants
n=10 Participants
|
|
American Rheumatism Association Functional Class
Class III
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
101 Participants
n=10 Participants
|
|
Corticosteroid User
Yes
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
232 Participants
n=10 Participants
|
|
Corticosteroid User
No
|
111 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
529 Participants
n=10 Participants
|
|
Disease Modifying Antirheumatic Drug User
Yes
|
133 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
629 Participants
n=10 Participants
|
|
Disease Modifying Antirheumatic Drug User
No
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
132 Participants
n=10 Participants
|
|
Disease Modifying Antirheumatic Drug or Corticosteroid User
Yes
|
139 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
654 Participants
n=10 Participants
|
|
Disease Modifying Antirheumatic Drug or Corticosteroid User
No
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
107 Participants
n=10 Participants
|
|
Methotrexate User
Yes
|
99 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
472 Participants
n=10 Participants
|
|
Methotrexate User
No
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
289 Participants
n=10 Participants
|
|
Race/Ethnicity
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=10 Participants
|
|
Race/Ethnicity
Black
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
29 participants
n=10 Participants
|
|
Race/Ethnicity
White
|
114 participants
n=5 Participants
|
106 participants
n=7 Participants
|
121 participants
n=5 Participants
|
96 participants
n=4 Participants
|
112 participants
n=21 Participants
|
549 participants
n=10 Participants
|
|
Race/Ethnicity
Hispanic
|
41 participants
n=5 Participants
|
39 participants
n=7 Participants
|
25 participants
n=5 Participants
|
34 participants
n=4 Participants
|
36 participants
n=21 Participants
|
175 participants
n=10 Participants
|
|
Race/Ethnicity
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Race/Ethnicity
Indian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Rheumatoid Factor
Positive
|
120 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
599 Participants
n=10 Participants
|
|
Rheumatoid Factor
Negative
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
161 Participants
n=10 Participants
|
|
Rheumatoid Factor
Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Smoking Status
Current
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
129 Participants
n=10 Participants
|
|
Smoking Status
Ex-User
|
53 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
220 Participants
n=10 Participants
|
|
Smoking Status
Non-User
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
412 Participants
n=10 Participants
|
|
Body Weight
|
76.42 Kilograms
STANDARD_DEVIATION 16.54 • n=5 Participants
|
76.12 Kilograms
STANDARD_DEVIATION 18.48 • n=7 Participants
|
77.36 Kilograms
STANDARD_DEVIATION 20.00 • n=5 Participants
|
75.72 Kilograms
STANDARD_DEVIATION 19.54 • n=4 Participants
|
77.97 Kilograms
STANDARD_DEVIATION 18.61 • n=21 Participants
|
76.73 Kilograms
STANDARD_DEVIATION 18.58 • n=10 Participants
|
|
Duration of Rheumatoid Arthritis (Years)
|
10.0 Years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
10.1 Years
STANDARD_DEVIATION 9.76 • n=7 Participants
|
11.2 Years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
10.3 Years
STANDARD_DEVIATION 10.18 • n=4 Participants
|
9.9 Years
STANDARD_DEVIATION 9.98 • n=21 Participants
|
10.3 Years
STANDARD_DEVIATION 9.62 • n=10 Participants
|
|
Height
|
161.93 Centimeters
STANDARD_DEVIATION 9.71 • n=5 Participants
|
163.63 Centimeters
STANDARD_DEVIATION 8.55 • n=7 Participants
|
164.57 Centimeters
STANDARD_DEVIATION 9.13 • n=5 Participants
|
162.96 Centimeters
STANDARD_DEVIATION 9.22 • n=4 Participants
|
163.49 Centimeters
STANDARD_DEVIATION 10.04 • n=21 Participants
|
163.30 Centimeters
STANDARD_DEVIATION 9.37 • n=10 Participants
|
|
Investigator Global Assessment of Disease Activity (0 to 4 - Likert Scale)
|
2.71 units on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
2.71 units on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
2.75 units on a scale
STANDARD_DEVIATION 0.66 • n=5 Participants
|
2.69 units on a scale
STANDARD_DEVIATION 0.63 • n=4 Participants
|
2.73 units on a scale
STANDARD_DEVIATION 0.65 • n=21 Participants
|
2.72 units on a scale
STANDARD_DEVIATION 0.64 • n=10 Participants
|
|
Patient Global Assessment of Disease Activity (0-To- 100 Millimeter Visual Analog Scale)
|
66.08 units on a scale
STANDARD_DEVIATION 18.67 • n=5 Participants
|
69.28 units on a scale
STANDARD_DEVIATION 19.37 • n=7 Participants
|
66.56 units on a scale
STANDARD_DEVIATION 20.47 • n=5 Participants
|
66.60 units on a scale
STANDARD_DEVIATION 19.58 • n=4 Participants
|
65.42 units on a scale
STANDARD_DEVIATION 18.45 • n=21 Participants
|
66.79 units on a scale
STANDARD_DEVIATION 19.30 • n=10 Participants
|
|
Patient Global Assessment of Pain (0- To- 100-mm Visual Analog Scale)
|
72.66 units on a scale
STANDARD_DEVIATION 16.03 • n=5 Participants
|
72.42 units on a scale
STANDARD_DEVIATION 17.32 • n=7 Participants
|
70.95 units on a scale
STANDARD_DEVIATION 16.67 • n=5 Participants
|
69.54 units on a scale
STANDARD_DEVIATION 18.24 • n=4 Participants
|
71.08 units on a scale
STANDARD_DEVIATION 17.55 • n=21 Participants
|
71.38 units on a scale
STANDARD_DEVIATION 17.14 • n=10 Participants
|
|
Swollen Joint Count (Out of 66 Joints)
|
16.05 Number of Swollen Joints
STANDARD_DEVIATION 9.79 • n=5 Participants
|
17.75 Number of Swollen Joints
STANDARD_DEVIATION 10.86 • n=7 Participants
|
16.74 Number of Swollen Joints
STANDARD_DEVIATION 10.11 • n=5 Participants
|
15.79 Number of Swollen Joints
STANDARD_DEVIATION 9.40 • n=4 Participants
|
16.30 Number of Swollen Joints
STANDARD_DEVIATION 10.05 • n=21 Participants
|
16.53 Number of Swollen Joints
STANDARD_DEVIATION 10.06 • n=10 Participants
|
|
Tender Joint Count (Out of 68 Joints)
|
26.91 Number of Tender Joints
STANDARD_DEVIATION 14.17 • n=5 Participants
|
28.33 Number of Tender Joints
STANDARD_DEVIATION 15.42 • n=7 Participants
|
27.19 Number of Tender Joints
STANDARD_DEVIATION 14.97 • n=5 Participants
|
26.76 Number of Tender Joints
STANDARD_DEVIATION 14.37 • n=4 Participants
|
27.25 Number of Tender Joints
STANDARD_DEVIATION 16.11 • n=21 Participants
|
27.30 Number of Tender Joints
STANDARD_DEVIATION 15.00 • n=10 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All-Patients-Treated Population
Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)
Outcome measures
| Measure |
Placebo
n=161 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=154 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=151 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=140 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=155 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
|---|---|---|---|---|---|
|
Proportion of Patients Who Met the ACR20 Responder Index Criteria
|
28.57 Proportion of Patients
|
35.06 Proportion of Patients
|
37.75 Proportion of Patients
|
38.57 Proportion of Patients
|
47.10 Proportion of Patients
|
SECONDARY outcome
Timeframe: Time-weighted average change from baseline across Weeks 2, 7, and 12Population: All-Patients-Treatment Population
Outcome measures
| Measure |
Placebo
n=157 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=148 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=146 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=138 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=148 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
|---|---|---|---|---|---|
|
Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
|
-8.13 Tender Joint Count
Standard Deviation 9.55
|
-11.01 Tender Joint Count
Standard Deviation 13.07
|
-10.96 Tender Joint Count
Standard Deviation 11.00
|
-9.56 Tender Joint Count
Standard Deviation 11.85
|
-12.06 Tender Joint Count
Standard Deviation 11.22
|
SECONDARY outcome
Timeframe: Time-weighted average change from baseline across Weeks 2, 7, and 12Population: All-Patients-Treatment Population
Outcome measures
| Measure |
Placebo
n=157 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=148 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=146 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=138 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=148 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
|---|---|---|---|---|---|
|
Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
|
-5.39 Swollen Joint Count
Standard Deviation 7.34
|
-6.58 Swollen Joint Count
Standard Deviation 8.11
|
-6.91 Swollen Joint Count
Standard Deviation 7.27
|
-6.25 Swollen Joint Count
Standard Deviation 7.48
|
-7.77 Swollen Joint Count
Standard Deviation 7.17
|
SECONDARY outcome
Timeframe: Time-weighted average change from baseline across Weeks 2, 7, and 12Population: All Patients-Treated Population
0-mm indicates very well, 100-mm indicates very poor.
Outcome measures
| Measure |
Placebo
n=155 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=144 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=141 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=134 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=144 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
|---|---|---|---|---|---|
|
Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
|
-12.32 Units on a Scale
Standard Deviation 25.66
|
-19.90 Units on a Scale
Standard Deviation 23.61
|
-21.12 Units on a Scale
Standard Deviation 24.47
|
-21.49 Units on a Scale
Standard Deviation 26.71
|
-25.75 Units on a Scale
Standard Deviation 25.71
|
SECONDARY outcome
Timeframe: Time-weighted average change from baseline across Weeks 2, 7, and 12Population: All-Patients-Treatment Population
0 indicates very well, 4 indicates very poor.
Outcome measures
| Measure |
Placebo
n=157 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=148 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=146 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=138 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=148 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
|---|---|---|---|---|---|
|
Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
|
-0.68 Units on a Scale
Standard Deviation 1.06
|
-0.93 Units on a Scale
Standard Deviation 0.94
|
-1.09 Units on a Scale
Standard Deviation 1.01
|
-1.01 Units on a Scale
Standard Deviation 0.94
|
-1.24 Units on a Scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Time-weighted average change from baseline across Weeks 2, 7, and 12Population: All-Patients-Treated Population
0-mm indicates very well, 100-mm indicates very poor.
Outcome measures
| Measure |
Placebo
n=157 Participants
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg
n=148 Participants
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg
n=146 Participants
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg
n=137 Participants
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg
n=148 Participants
Treatment I: Etoricoxib 90 mg orally once daily
|
|---|---|---|---|---|---|
|
Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
|
-17.44 Units on a Scale
Standard Deviation 23.42
|
-21.95 Units on a Scale
Standard Deviation 22.87
|
-22.75 Units on a Scale
Standard Deviation 23.86
|
-22.25 Units on a Scale
Standard Deviation 26.58
|
-31.07 Units on a Scale
Standard Deviation 24.18
|
Adverse Events
Placebo Treatment I Period
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Etoricoxib 10 mg Treatment I Period
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Etoricoxib 30 mg Treatment I Period
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Etoricoxib 60 mg Treatment I Period
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Etoricoxib 90 mg Treatment I Period
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Etoricoxib 90 mg Treatment II Period
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Diclofenac 150 mg Treatment II Period
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Treatment I Period
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg Treatment I Period
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg Treatment I Period
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg Treatment I Period
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg Treatment I Period
Treatment I: Etoricoxib 90 mg orally once daily
|
Etoricoxib 90 mg Treatment II Period
Treatment II: Etoricoxib 90 mg orally once daily
|
Diclofenac 150 mg Treatment II Period
Treatment II: Diclofenac 75 mg orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.65%
1/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Infections and infestations
Cellulitis
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.65%
1/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Infections and infestations
Erysipelas
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.67%
1/149
|
|
Injury, poisoning and procedural complications
Dislocation Of Joint Prosthesis
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.65%
1/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.56%
1/180
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Heat Exhaustion
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.65%
1/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.71%
1/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma In Situ
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.67%
1/149
|
|
Psychiatric disorders
Depression
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.65%
1/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Psychiatric disorders
Obsessive-Compulsive Disorder
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.67%
1/149
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.56%
1/180
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/161
|
0.00%
0/154
|
0.66%
1/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.56%
1/180
|
0.00%
0/149
|
|
Vascular disorders
Hypertension
|
0.00%
0/161
|
0.65%
1/154
|
0.00%
0/151
|
0.00%
0/140
|
0.00%
0/155
|
0.00%
0/180
|
0.00%
0/149
|
Other adverse events
| Measure |
Placebo Treatment I Period
Treatment I: Placebo orally once daily
|
Etoricoxib 10 mg Treatment I Period
Treatment I: Etoricoxib 10 mg orally once daily
|
Etoricoxib 30 mg Treatment I Period
Treatment I: Etoricoxib 30 mg orally once daily
|
Etoricoxib 60 mg Treatment I Period
Treatment I: Etoricoxib 60 mg orally once daily
|
Etoricoxib 90 mg Treatment I Period
Treatment I: Etoricoxib 90 mg orally once daily
|
Etoricoxib 90 mg Treatment II Period
Treatment II: Etoricoxib 90 mg orally once daily
|
Diclofenac 150 mg Treatment II Period
Treatment II: Diclofenac 75 mg orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/161
|
0.00%
0/154
|
0.00%
0/151
|
0.00%
0/140
|
0.65%
1/155
|
0.00%
0/180
|
2.0%
3/149
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.2%
2/161
|
0.65%
1/154
|
0.66%
1/151
|
2.1%
3/140
|
1.3%
2/155
|
0.00%
0/180
|
1.3%
2/149
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/161
|
0.65%
1/154
|
3.3%
5/151
|
2.1%
3/140
|
1.3%
2/155
|
0.56%
1/180
|
0.67%
1/149
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/161
|
2.6%
4/154
|
1.3%
2/151
|
5.7%
8/140
|
4.5%
7/155
|
2.2%
4/180
|
4.0%
6/149
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
5/161
|
1.3%
2/154
|
0.66%
1/151
|
2.1%
3/140
|
3.9%
6/155
|
1.1%
2/180
|
2.7%
4/149
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/161
|
1.3%
2/154
|
1.3%
2/151
|
2.1%
3/140
|
1.9%
3/155
|
0.00%
0/180
|
1.3%
2/149
|
|
General disorders
Oedema Peripheral
|
0.62%
1/161
|
1.3%
2/154
|
1.3%
2/151
|
3.6%
5/140
|
0.65%
1/155
|
3.3%
6/180
|
2.7%
4/149
|
|
Infections and infestations
Nasopharyngitis
|
0.62%
1/161
|
2.6%
4/154
|
0.00%
0/151
|
0.71%
1/140
|
2.6%
4/155
|
1.1%
2/180
|
0.67%
1/149
|
|
Infections and infestations
Sinusitis
|
1.9%
3/161
|
0.65%
1/154
|
0.00%
0/151
|
0.71%
1/140
|
2.6%
4/155
|
1.1%
2/180
|
0.67%
1/149
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.5%
4/161
|
0.00%
0/154
|
2.6%
4/151
|
0.71%
1/140
|
1.3%
2/155
|
2.2%
4/180
|
4.7%
7/149
|
|
Infections and infestations
Urinary Tract Infection
|
0.62%
1/161
|
0.65%
1/154
|
2.0%
3/151
|
0.00%
0/140
|
0.00%
0/155
|
1.1%
2/180
|
0.67%
1/149
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.9%
3/161
|
0.65%
1/154
|
2.0%
3/151
|
2.9%
4/140
|
1.3%
2/155
|
0.56%
1/180
|
2.0%
3/149
|
|
Nervous system disorders
Dizziness
|
0.62%
1/161
|
0.65%
1/154
|
1.3%
2/151
|
2.9%
4/140
|
3.9%
6/155
|
0.00%
0/180
|
0.67%
1/149
|
|
Nervous system disorders
Headache
|
3.7%
6/161
|
2.6%
4/154
|
3.3%
5/151
|
5.7%
8/140
|
3.2%
5/155
|
1.1%
2/180
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.62%
1/161
|
0.65%
1/154
|
0.00%
0/151
|
2.1%
3/140
|
1.3%
2/155
|
0.00%
0/180
|
0.67%
1/149
|
|
Vascular disorders
Hypertension
|
0.00%
0/161
|
1.3%
2/154
|
2.0%
3/151
|
4.3%
6/140
|
3.2%
5/155
|
3.3%
6/180
|
0.67%
1/149
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER