Trial Outcomes & Findings for Duloxetine Versus Placebo in Chronic Low Back Pain (NCT NCT00408876)
NCT ID: NCT00408876
Last Updated: 2009-12-29
Results Overview
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
COMPLETED
PHASE3
404 participants
Baseline, Week 1
2009-12-29
Participant Flow
Participant milestones
| Measure |
Duloxetine 20 mg
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
116
|
112
|
117
|
|
Overall Study
COMPLETED
|
43
|
80
|
62
|
82
|
|
Overall Study
NOT COMPLETED
|
16
|
36
|
50
|
35
|
Reasons for withdrawal
| Measure |
Duloxetine 20 mg
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
17
|
27
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
6
|
14
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
5
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
4
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
3
|
0
|
Baseline Characteristics
Duloxetine Versus Placebo in Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Duloxetine 20 mg
n=59 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=116 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=112 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=117 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
52.93 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
53.32 years
STANDARD_DEVIATION 14.69 • n=7 Participants
|
54.92 years
STANDARD_DEVIATION 14.77 • n=5 Participants
|
53.97 years
STANDARD_DEVIATION 13.52 • n=4 Participants
|
53.89 years
STANDARD_DEVIATION 14.09 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
92 participants
n=7 Participants
|
85 participants
n=5 Participants
|
93 participants
n=4 Participants
|
316 participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
13 participants
n=5 Participants
|
24 participants
n=7 Participants
|
27 participants
n=5 Participants
|
24 participants
n=4 Participants
|
88 participants
n=21 Participants
|
|
Race/Ethnicity
African
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Race/Ethnicity
Caucasian
|
46 participants
n=5 Participants
|
91 participants
n=7 Participants
|
92 participants
n=5 Participants
|
93 participants
n=4 Participants
|
322 participants
n=21 Participants
|
|
Race/Ethnicity
East Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity
Hispanic
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Race/Ethnicity
West Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Beck Depression Inventory-II Total Score
|
6.02 units on a scale
STANDARD_DEVIATION 6.33 • n=5 Participants
|
7.05 units on a scale
STANDARD_DEVIATION 7.17 • n=7 Participants
|
5.20 units on a scale
STANDARD_DEVIATION 5.00 • n=5 Participants
|
6.15 units on a scale
STANDARD_DEVIATION 7.52 • n=4 Participants
|
6.12 units on a scale
STANDARD_DEVIATION 6.64 • n=21 Participants
|
|
Body Mass Index
|
30.42 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.54 • n=5 Participants
|
28.85 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.73 • n=7 Participants
|
29.23 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.68 • n=5 Participants
|
28.67 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.89 • n=4 Participants
|
29.13 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 4.75 • n=21 Participants
|
|
Brief Pain Inventory (BPI) 24-Hour Average Pain Score
|
6.34 units on a scale
STANDARD_DEVIATION 1.64 • n=5 Participants
|
5.93 units on a scale
STANDARD_DEVIATION 1.67 • n=7 Participants
|
6.04 units on a scale
STANDARD_DEVIATION 1.63 • n=5 Participants
|
6.14 units on a scale
STANDARD_DEVIATION 1.66 • n=4 Participants
|
6.08 units on a scale
STANDARD_DEVIATION 1.65 • n=21 Participants
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
|
4.05 units on a scale
STANDARD_DEVIATION 1.41 • n=5 Participants
|
3.54 units on a scale
STANDARD_DEVIATION 1.40 • n=7 Participants
|
3.58 units on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
3.66 units on a scale
STANDARD_DEVIATION 1.30 • n=4 Participants
|
3.66 units on a scale
STANDARD_DEVIATION 1.36 • n=21 Participants
|
|
Duration of Chronic Low Back Pain
|
12.50 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
10.48 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
13.94 years
STANDARD_DEVIATION 12.97 • n=5 Participants
|
10.29 years
STANDARD_DEVIATION 9.53 • n=4 Participants
|
11.68 years
STANDARD_DEVIATION 11.38 • n=21 Participants
|
|
Patient Global Impressions of Severity (PGI-S) Scale
|
2.78 units on a scale
STANDARD_DEVIATION 1.69 • n=5 Participants
|
2.63 units on a scale
STANDARD_DEVIATION 1.78 • n=7 Participants
|
2.25 units on a scale
STANDARD_DEVIATION 1.58 • n=5 Participants
|
2.38 units on a scale
STANDARD_DEVIATION 1.60 • n=4 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 1.67 • n=21 Participants
|
|
Roland-Morris Disability Questionnaire Total Score
|
10.00 units on a scale
STANDARD_DEVIATION 4.82 • n=5 Participants
|
8.91 units on a scale
STANDARD_DEVIATION 4.56 • n=7 Participants
|
8.72 units on a scale
STANDARD_DEVIATION 4.82 • n=5 Participants
|
8.32 units on a scale
STANDARD_DEVIATION 4.92 • n=4 Participants
|
8.85 units on a scale
STANDARD_DEVIATION 4.79 • n=21 Participants
|
|
Weekly Mean of 24-Hour Average Pain Severity
|
6.42 units on a scale
STANDARD_DEVIATION 1.39 • n=5 Participants
|
6.18 units on a scale
STANDARD_DEVIATION 1.44 • n=7 Participants
|
6.06 units on a scale
STANDARD_DEVIATION 1.45 • n=5 Participants
|
6.18 units on a scale
STANDARD_DEVIATION 1.25 • n=4 Participants
|
6.18 units on a scale
STANDARD_DEVIATION 1.38 • n=21 Participants
|
|
Weekly Mean of 24-Hour Worst Pain Severity
|
7.41 units on a scale
STANDARD_DEVIATION 1.31 • n=5 Participants
|
7.22 units on a scale
STANDARD_DEVIATION 1.32 • n=7 Participants
|
7.22 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
7.35 units on a scale
STANDARD_DEVIATION 1.20 • n=4 Participants
|
7.29 units on a scale
STANDARD_DEVIATION 1.27 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=110 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores
|
-0.54 units on a scale
Standard Error 0.18
|
-0.53 units on a scale
Standard Error 0.13
|
-0.71 units on a scale
Standard Error 0.13
|
-0.39 units on a scale
Standard Error 0.13
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=53 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=106 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores
|
-0.84 units on a scale
Standard Error 0.25
|
-0.91 units on a scale
Standard Error 0.18
|
-1.22 units on a scale
Standard Error 0.18
|
-0.75 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Baseline, Week 3Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=50 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=103 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=97 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=107 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.05 units on a scale
Standard Error 0.26
|
-1.58 units on a scale
Standard Error 0.18
|
-1.71 units on a scale
Standard Error 0.19
|
-1.01 units on a scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=49 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=93 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=104 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.20 units on a scale
Standard Error 0.26
|
-1.70 units on a scale
Standard Error 0.18
|
-2.17 units on a scale
Standard Error 0.19
|
-1.02 units on a scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline, Week 5Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=46 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=89 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=70 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=91 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.45 units on a scale
Standard Error 0.25
|
-1.94 units on a scale
Standard Error 0.18
|
-2.25 units on a scale
Standard Error 0.18
|
-1.26 units on a scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=44 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=93 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=73 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=93 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.64 units on a scale
Standard Error 0.24
|
-2.10 units on a scale
Standard Error 0.17
|
-2.28 units on a scale
Standard Error 0.18
|
-1.34 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Baseline, Week 7Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=44 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=91 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=72 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=93 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.68 units on a scale
Standard Error 0.24
|
-2.17 units on a scale
Standard Error 0.17
|
-2.36 units on a scale
Standard Error 0.18
|
-1.57 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=43 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=85 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=65 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=80 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.68 units on a scale
Standard Error 0.24
|
-2.29 units on a scale
Standard Error 0.17
|
-2.49 units on a scale
Standard Error 0.18
|
-1.65 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Baseline, Week 9Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=44 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=85 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=64 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=88 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.57 units on a scale
Standard Error 0.23
|
-2.21 units on a scale
Standard Error 0.17
|
-2.45 units on a scale
Standard Error 0.18
|
-1.71 units on a scale
Standard Error 0.16
|
PRIMARY outcome
Timeframe: Baseline, Week 10Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=43 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=83 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=60 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=87 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.77 units on a scale
Standard Error 0.23
|
-2.24 units on a scale
Standard Error 0.17
|
-2.58 units on a scale
Standard Error 0.18
|
-1.73 units on a scale
Standard Error 0.16
|
PRIMARY outcome
Timeframe: Baseline, Week 11Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=41 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=81 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=61 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=85 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.88 units on a scale
Standard Error 0.23
|
-2.32 units on a scale
Standard Error 0.17
|
-2.62 units on a scale
Standard Error 0.19
|
-1.79 units on a scale
Standard Error 0.16
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=39 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=78 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=57 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=80 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.87 units on a scale
Standard Error 0.24
|
-2.34 units on a scale
Standard Error 0.17
|
-2.46 units on a scale
Standard Error 0.19
|
-1.91 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=41 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=74 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=56 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=74 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores
|
-1.74 units on a scale
Standard Error 0.25
|
-2.50 units on a scale
Standard Error 0.18
|
-2.42 units on a scale
Standard Error 0.20
|
-2.10 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine 20 mg
n=57 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint
|
2.72 units on a scale
Standard Error 0.17
|
2.44 units on a scale
Standard Error 0.13
|
2.66 units on a scale
Standard Error 0.13
|
2.93 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Duloxetine 20 mg
n=52 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=83 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=83 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=92 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score
|
-2.29 units on a scale
Standard Error 0.56
|
-2.74 units on a scale
Standard Error 0.44
|
-2.88 units on a scale
Standard Error 0.45
|
-1.33 units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=109 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score
|
-1.77 units on a scale
Standard Error 0.27
|
-2.15 units on a scale
Standard Error 0.20
|
-2.47 units on a scale
Standard Error 0.20
|
-1.91 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=109 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score
|
-1.77 units on a scale
Standard Error 0.30
|
-2.46 units on a scale
Standard Error 0.22
|
-2.40 units on a scale
Standard Error 0.22
|
-2.10 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=112 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity
|
-0.53 units on a scale
Standard Error 0.14
|
-0.94 units on a scale
Standard Error 0.11
|
-1.06 units on a scale
Standard Error 0.11
|
-0.53 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score
|
-1.78 units on a scale
Standard Error 0.35
|
-2.77 units on a scale
Standard Error 0.25
|
-2.78 units on a scale
Standard Error 0.26
|
-2.09 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score
|
-1.30 units on a scale
Standard Error 0.29
|
-2.06 units on a scale
Standard Error 0.21
|
-2.16 units on a scale
Standard Error 0.21
|
-1.51 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score
|
-1.79 units on a scale
Standard Error 0.30
|
-2.50 units on a scale
Standard Error 0.22
|
-2.45 units on a scale
Standard Error 0.22
|
-1.87 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score
|
-1.63 units on a scale
Standard Error 0.33
|
-2.67 units on a scale
Standard Error 0.24
|
-2.61 units on a scale
Standard Error 0.24
|
-1.74 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity
|
-1.99 units on a scale
Standard Error 0.33
|
-2.52 units on a scale
Standard Error 0.24
|
-2.36 units on a scale
Standard Error 0.25
|
-1.97 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood
|
-1.75 units on a scale
Standard Error 0.30
|
-2.52 units on a scale
Standard Error 0.22
|
-1.96 units on a scale
Standard Error 0.22
|
-1.70 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability
|
-1.79 units on a scale
Standard Error 0.34
|
-2.33 units on a scale
Standard Error 0.25
|
-1.89 units on a scale
Standard Error 0.25
|
-1.43 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work
|
-2.20 units on a scale
Standard Error 0.36
|
-2.67 units on a scale
Standard Error 0.26
|
-2.38 units on a scale
Standard Error 0.26
|
-1.95 units on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People
|
-1.33 units on a scale
Standard Error 0.27
|
-1.86 units on a scale
Standard Error 0.20
|
-1.27 units on a scale
Standard Error 0.20
|
-0.94 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep
|
-1.59 units on a scale
Standard Error 0.32
|
-2.48 units on a scale
Standard Error 0.24
|
-2.12 units on a scale
Standard Error 0.24
|
-1.63 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life
|
-1.84 units on a scale
Standard Error 0.32
|
-2.49 units on a scale
Standard Error 0.24
|
-1.86 units on a scale
Standard Error 0.24
|
-1.76 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference
|
-1.84 units on a scale
Standard Error 0.26
|
-2.40 units on a scale
Standard Error 0.19
|
-1.92 units on a scale
Standard Error 0.19
|
-1.61 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline to Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=109 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward
|
23 participants
|
59 participants
|
63 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=109 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward
|
12 participants
|
38 participants
|
40 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=99 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=107 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale
|
-1.43 units on a scale
Standard Error 0.53
|
-2.30 units on a scale
Standard Error 0.39
|
-0.93 units on a scale
Standard Error 0.40
|
-1.23 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)
|
0.01 units on a scale
Standard Error 1.11
|
0.57 units on a scale
Standard Error 0.81
|
-1.26 units on a scale
Standard Error 0.82
|
-0.45 units on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)
|
6.07 units on a scale
Standard Error 1.22
|
7.01 units on a scale
Standard Error 0.88
|
7.85 units on a scale
Standard Error 0.89
|
6.11 units on a scale
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Bodily pain scores range from 2-11 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain
|
1.51 units on a scale
Standard Error 0.27
|
1.95 units on a scale
Standard Error 0.20
|
2.11 units on a scale
Standard Error 0.20
|
1.36 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). General health scores range from 5-25(higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health
|
0.70 units on a scale
Standard Error 0.41
|
1.24 units on a scale
Standard Error 0.30
|
0.81 units on a scale
Standard Error 0.30
|
0.66 units on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Mental health scores range from 5-30 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health
|
0.21 units on a scale
Standard Error 0.49
|
0.98 units on a scale
Standard Error 0.36
|
0.46 units on a scale
Standard Error 0.36
|
0.38 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Physical functioning scores range from 10-30 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning
|
1.80 units on a scale
Standard Error 0.52
|
2.55 units on a scale
Standard Error 0.38
|
3.11 units on a scale
Standard Error 0.38
|
2.23 units on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Role-emotional scores range from 3-6 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional
|
0.10 units on a scale
Standard Error 0.12
|
0.19 units on a scale
Standard Error 0.09
|
0.14 units on a scale
Standard Error 0.09
|
0.08 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Role-physical scores range from 4-8 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical
|
0.81 units on a scale
Standard Error 0.21
|
0.80 units on a scale
Standard Error 0.15
|
0.85 units on a scale
Standard Error 0.15
|
0.80 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Social functioning scores range from 2-10 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning
|
0.75 units on a scale
Standard Error 0.21
|
0.46 units on a scale
Standard Error 0.16
|
0.38 units on a scale
Standard Error 0.16
|
0.50 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Vitality scores range from 4-24 (higher scores indicate better health status).
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=101 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=108 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality
|
0.69 units on a scale
Standard Error 0.50
|
1.43 units on a scale
Standard Error 0.36
|
0.44 units on a scale
Standard Error 0.37
|
0.91 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=100 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=104 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score
|
0.04 units on a scale
Standard Error 0.02
|
0.07 units on a scale
Standard Error 0.01
|
0.08 units on a scale
Standard Error 0.02
|
0.05 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Duloxetine 20 mg
n=57 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=109 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score
|
-1.24 units on a scale
Standard Error 0.68
|
-1.54 units on a scale
Standard Error 0.50
|
0.37 units on a scale
Standard Error 0.50
|
-1.02 units on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Outcome measures
| Measure |
Duloxetine 20 mg
n=54 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=100 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=106 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale
|
-0.30 units on a scale
Standard Error 0.36
|
-0.81 units on a scale
Standard Error 0.27
|
-0.91 units on a scale
Standard Error 0.27
|
-0.68 units on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline to Week 13Population: Number of all randomized patients.
Outcome measures
| Measure |
Duloxetine 20 mg
n=59 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=116 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=112 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=117 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Adverse Events Reported as Reason for Discontinuation
Disturbance in attention
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Dysphoria
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Ejaculation disorder
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Trismus
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Patients Discontinued for Any Adverse Event
|
9 participants
|
17 participants
|
27 participants
|
10 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Insomnia
|
1 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Nausea
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Vomiting
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Anxiety
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Constipation
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Diarrhoea
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Dizziness
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Dyspepsia
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Erectile dysfunction
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Hepatic enzyme increased
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Somnolence
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Abdominal pain
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Abdominal pain upper
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Apathy
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Bursitis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Confusional state
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Coordination abnormal
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Decreased appetite
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Fatigue
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Gastroenteritis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Glaucoma
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Headache
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Hepatitis
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Hot flush
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Hyperhidrosis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Hypertension
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Irritability
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Lethargy
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Loss of libido
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Muscular weakness
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Myocardial infarction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Palpitations
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Peritonsillar abscess
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Pregnancy
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Rash
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Restless legs syndrome
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Sedation
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Testicular pain
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase
|
-1.19 Units/Liter
Standard Deviation 11.19
|
3.27 Units/Liter
Standard Deviation 14.17
|
1.11 Units/Liter
Standard Deviation 12.37
|
-1.43 Units/Liter
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=106 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=112 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase
|
-1.39 Units/Liter
Standard Deviation 10.91
|
0.25 Units/Liter
Standard Deviation 21.53
|
2.20 Units/Liter
Standard Deviation 12.45
|
-0.06 Units/Liter
Standard Deviation 9.48
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=57 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=106 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=112 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3
|
1.04 millimole/Liter
Standard Deviation 3.29
|
1.18 millimole/Liter
Standard Deviation 3.60
|
1.72 millimole/Liter
Standard Deviation 2.93
|
1.35 millimole/Liter
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=105 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=102 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=112 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct
|
-0.29 micromole/Liter
Standard Deviation 0.68
|
-0.13 micromole/Liter
Standard Deviation 0.82
|
-0.13 micromole/Liter
Standard Deviation 0.74
|
0.07 micromole/Liter
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=57 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=106 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total
|
-1.05 micromole/Liter
Standard Deviation 2.56
|
-0.23 micromole/Liter
Standard Deviation 3.50
|
-0.58 micromole/Liter
Standard Deviation 2.57
|
0.18 micromole/Liter
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride
|
-0.22 millimole/Liter
Standard Deviation 2.44
|
-0.54 millimole/Liter
Standard Deviation 2.81
|
-0.99 millimole/Liter
Standard Deviation 2.55
|
-0.47 millimole/Liter
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol
|
-0.04 millimole/Liter
Standard Deviation 0.74
|
-0.09 millimole/Liter
Standard Deviation 0.70
|
0.01 millimole/Liter
Standard Deviation 0.88
|
-0.22 millimole/Liter
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine
|
-11.43 micromole/Liter
Standard Deviation 89.68
|
-0.66 micromole/Liter
Standard Deviation 8.96
|
1.34 micromole/Liter
Standard Deviation 9.91
|
2.02 micromole/Liter
Standard Deviation 10.36
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=56 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=113 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium
|
-0.02 millimole/Liter
Standard Deviation 0.41
|
0.00 millimole/Liter
Standard Deviation 0.42
|
0.06 millimole/Liter
Standard Deviation 0.44
|
-0.08 millimole/Liter
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=107 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=104 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid
|
-9.48 micromole/Liter
Standard Deviation 45.82
|
-11.08 micromole/Liter
Standard Deviation 49.35
|
-11.31 micromole/Liter
Standard Deviation 50.54
|
8.20 micromole/Liter
Standard Deviation 37.89
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate
|
-1.10 beats per minute
Standard Error 1.21
|
2.79 beats per minute
Standard Error 0.89
|
1.90 beats per minute
Standard Error 0.90
|
0.29 beats per minute
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure
|
-0.64 mm Hg
Standard Error 1.68
|
-1.18 mm Hg
Standard Error 1.24
|
1.00 mm Hg
Standard Error 1.25
|
-1.04 mm Hg
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure
|
-0.51 mm Hg
Standard Error 1.14
|
-0.79 mm Hg
Standard Error 0.84
|
2.94 mm Hg
Standard Error 0.85
|
-0.68 mm Hg
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine 20 mg
n=58 Participants
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=110 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=108 Participants
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=114 Participants
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Vital Signs - Weight
|
-0.59 kilograms
Standard Error 0.30
|
-0.35 kilograms
Standard Error 0.22
|
-0.72 kilograms
Standard Error 0.22
|
0.10 kilograms
Standard Error 0.22
|
Adverse Events
Duloxetine 20 mg
Duloxetine 60 mg
Duloxetine 120 mg
Placebo
Serious adverse events
| Measure |
Duloxetine 20 mg
n=59 participants at risk
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=116 participants at risk
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=112 participants at risk
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=117 participants at risk
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/59
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/59
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/59
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/59
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
0.00%
0/117
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/59
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
0.00%
0/117
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/59
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/59
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
0.00%
0/117
|
Other adverse events
| Measure |
Duloxetine 20 mg
n=59 participants at risk
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
n=116 participants at risk
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
|
Duloxetine 120 mg
n=112 participants at risk
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
|
Placebo
n=117 participants at risk
placebo once a day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/59
|
2.6%
3/116 • Number of events 3
|
2.7%
3/112 • Number of events 3
|
0.00%
0/117
|
|
Eye disorders
Conjunctivitis
|
3.4%
2/59 • Number of events 2
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Eye disorders
Vision blurred
|
1.7%
1/59 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
0.85%
1/117 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.85%
1/117 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/59 • Number of events 2
|
8.6%
10/116 • Number of events 10
|
12.5%
14/112 • Number of events 14
|
0.85%
1/117 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • Number of events 2
|
8.6%
10/116 • Number of events 12
|
6.2%
7/112 • Number of events 8
|
3.4%
4/117 • Number of events 8
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
3/59 • Number of events 3
|
10.3%
12/116 • Number of events 13
|
10.7%
12/112 • Number of events 12
|
0.85%
1/117 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • Number of events 1
|
2.6%
3/116 • Number of events 3
|
2.7%
3/112 • Number of events 3
|
1.7%
2/117 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Gastrointestinal disorders
Nausea
|
18.6%
11/59 • Number of events 12
|
20.7%
24/116 • Number of events 24
|
12.5%
14/112 • Number of events 14
|
3.4%
4/117 • Number of events 6
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/59 • Number of events 2
|
1.7%
2/116 • Number of events 2
|
2.7%
3/112 • Number of events 3
|
0.85%
1/117 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/59
|
0.00%
0/116
|
2.7%
3/112 • Number of events 3
|
0.00%
0/117
|
|
General disorders
Fatigue
|
0.00%
0/59
|
6.0%
7/116 • Number of events 7
|
8.9%
10/112 • Number of events 10
|
0.00%
0/117
|
|
General disorders
Feeling abnormal
|
0.00%
0/59
|
1.7%
2/116 • Number of events 2
|
0.00%
0/112
|
0.00%
0/117
|
|
General disorders
Irritability
|
3.4%
2/59 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
0.85%
1/117 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
General disorders
Oedema peripheral
|
0.00%
0/59
|
0.00%
0/116
|
0.00%
0/112
|
1.7%
2/117 • Number of events 2
|
|
General disorders
Therapeutic response unexpected
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Immune system disorders
Drug hypersensitivity
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Infections and infestations
Bronchitis
|
0.00%
0/59
|
0.00%
0/116
|
0.00%
0/112
|
2.6%
3/117 • Number of events 3
|
|
Infections and infestations
Cystitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Infections and infestations
Folliculitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/59 • Number of events 1
|
2.6%
3/116 • Number of events 3
|
0.89%
1/112 • Number of events 1
|
0.85%
1/117 • Number of events 1
|
|
Infections and infestations
Influenza
|
5.1%
3/59 • Number of events 3
|
5.2%
6/116 • Number of events 6
|
4.5%
5/112 • Number of events 5
|
4.3%
5/117 • Number of events 5
|
|
Infections and infestations
Kidney infection
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/59 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
4.3%
5/117 • Number of events 5
|
|
Infections and infestations
Pharyngitis
|
6.8%
4/59 • Number of events 4
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
0.00%
0/117
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/59
|
1.7%
2/116 • Number of events 2
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
4.3%
5/117 • Number of events 5
|
|
Infections and infestations
Tooth abscess
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
1.7%
2/117 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/59 • Number of events 2
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.85%
1/117 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Investigations
Neurological examination abnormal
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Investigations
Weight increased
|
0.00%
0/59
|
0.00%
0/116
|
0.00%
0/112
|
1.7%
2/117 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/59 • Number of events 1
|
2.6%
3/116 • Number of events 3
|
2.7%
3/112 • Number of events 3
|
0.85%
1/117 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/59
|
4.3%
5/116 • Number of events 5
|
4.5%
5/112 • Number of events 5
|
0.00%
0/117
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
1.7%
2/117 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/59 • Number of events 2
|
4.3%
5/116 • Number of events 5
|
0.00%
0/112
|
1.7%
2/117 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/59 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
0.85%
1/117 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/59
|
2.6%
3/116 • Number of events 3
|
1.8%
2/112 • Number of events 2
|
0.85%
1/117 • Number of events 1
|
|
Nervous system disorders
Aphonia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • Number of events 3
|
7.8%
9/116 • Number of events 9
|
8.0%
9/112 • Number of events 9
|
2.6%
3/117 • Number of events 3
|
|
Nervous system disorders
Headache
|
3.4%
2/59 • Number of events 2
|
10.3%
12/116 • Number of events 15
|
8.9%
10/112 • Number of events 17
|
3.4%
4/117 • Number of events 4
|
|
Nervous system disorders
Hypersomnia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/59
|
3.4%
4/116 • Number of events 4
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Nervous system disorders
Lethargy
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59
|
1.7%
2/116 • Number of events 3
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Nervous system disorders
Sedation
|
0.00%
0/59
|
2.6%
3/116 • Number of events 3
|
2.7%
3/112 • Number of events 3
|
1.7%
2/117 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
5.1%
3/59 • Number of events 3
|
4.3%
5/116 • Number of events 5
|
12.5%
14/112 • Number of events 14
|
0.00%
0/117
|
|
Nervous system disorders
Tremor
|
0.00%
0/59
|
1.7%
2/116 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
0.85%
1/117 • Number of events 1
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/59
|
0.00%
0/116
|
2.7%
3/112 • Number of events 3
|
0.00%
0/117
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
1.7%
2/117 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/59 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
0.00%
0/117
|
|
Psychiatric disorders
Dysphoria
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Psychiatric disorders
Insomnia
|
10.2%
6/59 • Number of events 6
|
8.6%
10/116 • Number of events 11
|
18.8%
21/112 • Number of events 22
|
2.6%
3/117 • Number of events 3
|
|
Psychiatric disorders
Libido decreased
|
3.4%
2/59 • Number of events 2
|
1.7%
2/116 • Number of events 2
|
3.6%
4/112 • Number of events 4
|
0.00%
0/117
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/59
|
1.7%
2/116 • Number of events 2
|
3.6%
4/112 • Number of events 4
|
0.85%
1/117 • Number of events 1
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
3.6%
4/112 • Number of events 4
|
0.00%
0/117
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Breast cyst
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.7%
1/59 • Number of events 1
|
2.6%
3/116 • Number of events 3
|
2.7%
3/112 • Number of events 3
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/59
|
0.00%
0/116
|
1.8%
2/112 • Number of events 2
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.4%
2/59 • Number of events 2
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
1.7%
2/117 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.85%
1/117 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/59
|
1.7%
2/116 • Number of events 2
|
1.8%
2/112 • Number of events 2
|
0.85%
1/117 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/59
|
1.7%
2/116 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
4.5%
5/112 • Number of events 5
|
0.85%
1/117 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
2.7%
3/112 • Number of events 3
|
0.85%
1/117 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/59 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
0.00%
0/112
|
2.6%
3/117 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/59
|
0.86%
1/116 • Number of events 1
|
0.00%
0/112
|
1.7%
2/117 • Number of events 2
|
|
Surgical and medical procedures
Cardiac ablation
|
1.7%
1/59 • Number of events 1
|
0.00%
0/116
|
0.00%
0/112
|
0.00%
0/117
|
|
Vascular disorders
Hot flush
|
0.00%
0/59
|
4.3%
5/116 • Number of events 5
|
0.89%
1/112 • Number of events 1
|
0.00%
0/117
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • Number of events 1
|
2.6%
3/116 • Number of events 3
|
4.5%
5/112 • Number of events 5
|
1.7%
2/117 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60