Trial Outcomes & Findings for Duloxetine Versus Placebo for Osteoarthritis Knee Pain (NCT NCT00408421)
NCT ID: NCT00408421
Last Updated: 2009-08-19
Results Overview
This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).
COMPLETED
PHASE3
231 participants
Over 13 Weeks
2009-08-19
Participant Flow
Participant milestones
| Measure |
Placebo
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
|
Duloxetine 120 mg
Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
|
|---|---|---|---|
|
Treatment Initial Randomization
STARTED
|
120
|
111
|
0
|
|
Treatment Initial Randomization
COMPLETED
|
103
|
89
|
0
|
|
Treatment Initial Randomization
NOT COMPLETED
|
17
|
22
|
0
|
|
Treatment Re-Randomization
STARTED
|
103
|
46
|
43
|
|
Treatment Re-Randomization
COMPLETED
|
96
|
39
|
38
|
|
Treatment Re-Randomization
NOT COMPLETED
|
7
|
7
|
5
|
Reasons for withdrawal
| Measure |
Placebo
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60 mg
Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
|
Duloxetine 120 mg
Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
|
|---|---|---|---|
|
Treatment Initial Randomization
Adverse Event
|
5
|
9
|
0
|
|
Treatment Initial Randomization
Lack of Efficacy
|
2
|
2
|
0
|
|
Treatment Initial Randomization
Lost to Follow-up
|
0
|
3
|
0
|
|
Treatment Initial Randomization
Physician Decision
|
1
|
0
|
0
|
|
Treatment Initial Randomization
Protocol Violation
|
0
|
1
|
0
|
|
Treatment Initial Randomization
Withdrawal by Subject
|
7
|
7
|
0
|
|
Treatment Initial Randomization
Entry Criteria Not Met
|
1
|
0
|
0
|
|
Treatment Initial Randomization
Sponsor Decision
|
1
|
0
|
0
|
|
Treatment Re-Randomization
Adverse Event
|
2
|
2
|
4
|
|
Treatment Re-Randomization
Lack of Efficacy
|
1
|
0
|
0
|
|
Treatment Re-Randomization
Lost to Follow-up
|
0
|
0
|
1
|
|
Treatment Re-Randomization
Physician Decision
|
1
|
3
|
0
|
|
Treatment Re-Randomization
Protocol Violation
|
1
|
1
|
0
|
|
Treatment Re-Randomization
Withdrawal by Subject
|
2
|
1
|
0
|
Baseline Characteristics
Duloxetine Versus Placebo for Osteoarthritis Knee Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=120 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=111 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.48 years
STANDARD_DEVIATION 9.30 • n=113 Participants
|
62.07 years
STANDARD_DEVIATION 9.63 • n=163 Participants
|
62.28 years
STANDARD_DEVIATION 9.44 • n=160 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=113 Participants
|
70 Participants
n=163 Participants
|
151 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=113 Participants
|
41 Participants
n=163 Participants
|
80 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
African
|
6 participants
n=113 Participants
|
6 participants
n=163 Participants
|
12 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
100 participants
n=113 Participants
|
94 participants
n=163 Participants
|
194 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
3 participants
n=113 Participants
|
0 participants
n=163 Participants
|
3 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=113 Participants
|
9 participants
n=163 Participants
|
19 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=113 Participants
|
2 participants
n=163 Participants
|
3 participants
n=160 Participants
|
|
Non Steroidal Anti Inflammatory Drug Use
Yes
|
59 participants
n=113 Participants
|
58 participants
n=163 Participants
|
117 participants
n=160 Participants
|
|
Non Steroidal Anti Inflammatory Drug Use
No
|
61 participants
n=113 Participants
|
53 participants
n=163 Participants
|
114 participants
n=160 Participants
|
|
Brief Pain Inventory (BPI) Average Pain
|
6.23 units on a scale
STANDARD_DEVIATION 1.54 • n=113 Participants
|
6.16 units on a scale
STANDARD_DEVIATION 1.58 • n=163 Participants
|
6.20 units on a scale
STANDARD_DEVIATION 1.56 • n=160 Participants
|
|
Duration of Osteoarthritis (OA) Pain Since Onset
|
9.30 years
STANDARD_DEVIATION 8.27 • n=113 Participants
|
9.04 years
STANDARD_DEVIATION 8.72 • n=163 Participants
|
9.17 years
STANDARD_DEVIATION 8.47 • n=160 Participants
|
|
Duration of Osteoarthritis Since Diagnosis
|
7.09 years
STANDARD_DEVIATION 7.20 • n=113 Participants
|
6.94 years
STANDARD_DEVIATION 8.38 • n=163 Participants
|
7.01 years
STANDARD_DEVIATION 7.77 • n=160 Participants
|
|
Height
|
164.67 centimeters
STANDARD_DEVIATION 9.49 • n=113 Participants
|
167.01 centimeters
STANDARD_DEVIATION 8.81 • n=163 Participants
|
165.79 centimeters
STANDARD_DEVIATION 9.22 • n=160 Participants
|
|
Patient Global Impressions of Severity (PGI-Severity)
|
2.40 units on a scale
STANDARD_DEVIATION 1.64 • n=113 Participants
|
2.21 units on a scale
STANDARD_DEVIATION 1.51 • n=163 Participants
|
2.31 units on a scale
STANDARD_DEVIATION 1.58 • n=160 Participants
|
|
Weekly Mean of 24-Hour Average Pain Severity
|
6.18 units on a scale
STANDARD_DEVIATION 1.32 • n=113 Participants
|
6.10 units on a scale
STANDARD_DEVIATION 1.34 • n=163 Participants
|
6.14 units on a scale
STANDARD_DEVIATION 1.33 • n=160 Participants
|
|
Weight
|
85.66 kilograms
STANDARD_DEVIATION 15.12 • n=113 Participants
|
85.57 kilograms
STANDARD_DEVIATION 16.17 • n=163 Participants
|
85.61 kilograms
STANDARD_DEVIATION 15.60 • n=160 Participants
|
PRIMARY outcome
Timeframe: Over 13 WeeksPopulation: Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.
This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Placebo
n=119 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=103 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 1 (Change from Baseline): N=119, N=103
|
-0.36 units on a scale
Standard Error 0.15
|
-0.84 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 2 (Change from Baseline): N=112, N=101
|
-0.95 units on a scale
Standard Error 0.15
|
-1.54 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 3 (Change from Baseline): N=110, N=97
|
-1.23 units on a scale
Standard Error 0.15
|
-1.85 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 4 (Change from Baseline): N=109, N=96
|
-1.42 units on a scale
Standard Error 0.15
|
-2.10 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 5 (Change from Baseline): N=107, N=90
|
-1.55 units on a scale
Standard Error 0.15
|
-2.29 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 6 (Change from Baseline): N=108, N=92
|
-1.61 units on a scale
Standard Error 0.15
|
-2.41 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 7 (Change from Baseline): N=107, N=92
|
-1.72 units on a scale
Standard Error 0.15
|
-2.60 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 8 (Change from Baseline): N=86, N=78
|
-1.93 units on a scale
Standard Error 0.15
|
-2.60 units on a scale
Standard Error 0.16
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 9 (Change from Baseline): N=98, N=81
|
-1.89 units on a scale
Standard Error 0.15
|
-2.73 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 10 (Change from Baseline): N=99, N=80
|
-1.94 units on a scale
Standard Error 0.16
|
-2.74 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 11 (Change from Baseline): N=99, N=81
|
-1.94 units on a scale
Standard Error 0.16
|
-2.89 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 12 (Change from Baseline): N=98, N=80
|
-1.98 units on a scale
Standard Error 0.16
|
-2.93 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Week 13 (Change from Baseline): N=97, N=75
|
-2.08 units on a scale
Standard Error 0.16
|
-2.92 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Placebo
n=114 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Patient Global Impression of Improvement at 13 Week Endpoint
|
2.91 units on a scale
Standard Error 0.12
|
2.38 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).
Outcome measures
| Measure |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
Baseline
|
10.95 units on a scale
Standard Deviation 3.00
|
10.98 units on a scale
Standard Deviation 3.33
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
Change from Baseline
|
-3.19 units on a scale
Standard Deviation 3.87
|
-4.62 units on a scale
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).
Outcome measures
| Measure |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
Baseline
|
4.80 units on a scale
Standard Deviation 1.62
|
4.74 units on a scale
Standard Deviation 1.59
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
Change from Baseline
|
-1.37 units on a scale
Standard Deviation 1.88
|
-1.97 units on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).
Outcome measures
| Measure |
Placebo
n=115 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
Baseline
|
38.50 units on a scale
Standard Deviation 10.12
|
39.10 units on a scale
Standard Deviation 11.06
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
Change from Baseline
|
-11.58 units on a scale
Standard Deviation 12.39
|
-16.46 units on a scale
Standard Deviation 14.65
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).
Outcome measures
| Measure |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
Baseline
|
53.36 units on a scale
Standard Deviation 14.73
|
53.72 units on a scale
Standard Deviation 16.51
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
Change from Baseline
|
-15.93 units on a scale
Standard Deviation 17.53
|
-22.19 units on a scale
Standard Deviation 20.78
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.
Outcome measures
| Measure |
Placebo
n=119 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=108 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score
Baseline
|
7.54 units on a scale
Standard Deviation 1.32
|
7.45 units on a scale
Standard Deviation 1.12
|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score
Change from Baseline
|
-2.01 units on a scale
Standard Deviation 2.02
|
-2.81 units on a scale
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Over 13 WeeksPopulation: Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.
Outcome measures
| Measure |
Placebo
n=119 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=103 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 1 (Change from Baseline): N=119, N=103
|
-0.31 units on a scale
Standard Error 0.16
|
-0.82 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 2 (Change from Baseline): N=112, N=101
|
-0.92 units on a scale
Standard Error 0.16
|
-1.57 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 3 (Change from Baseline): N=110, N=97
|
-1.20 units on a scale
Standard Error 0.17
|
-1.99 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 4 (Change from Baseline): N=109, N=96
|
-1.41 units on a scale
Standard Error 0.17
|
-2.26 units on a scale
Standard Error 0.17
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 5 (Change from Baseline): N=107, N=90
|
-1.49 units on a scale
Standard Error 0.17
|
-2.40 units on a scale
Standard Error 0.18
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 6 (Change from Baseline): N=108, N=92
|
-1.57 units on a scale
Standard Error 0.17
|
-2.58 units on a scale
Standard Error 0.18
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 7 (Change from Baseline): N=107, N=92
|
-1.71 units on a scale
Standard Error 0.17
|
-2.82 units on a scale
Standard Error 0.18
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 8 (Change from Baseline): N=86, N=78
|
-1.95 units on a scale
Standard Error 0.17
|
-2.82 units on a scale
Standard Error 0.18
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 9 (Change from Baseline): N=98, N=81
|
-1.90 units on a scale
Standard Error 0.17
|
-2.94 units on a scale
Standard Error 0.18
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 10 (Change from Baseline): N=99, N=80
|
-1.97 units on a scale
Standard Error 0.17
|
-3.00 units on a scale
Standard Error 0.19
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 11 (Change from Baseline): N=99, N=81
|
-2.03 units on a scale
Standard Error 0.17
|
-3.12 units on a scale
Standard Error 0.19
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 12 (Change from Baseline): N=98, N=80
|
-2.04 units on a scale
Standard Error 0.17
|
-3.14 units on a scale
Standard Error 0.19
|
|
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Week 13 (Change from Baseline): N=97, N=75
|
-2.18 units on a scale
Standard Error 0.18
|
-3.19 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.
Outcome measures
| Measure |
Placebo
n=46 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=43 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase
Baseline
|
5.96 units on a scale
Standard Deviation 1.41
|
6.22 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase
Change from Baseline
|
-2.46 units on a scale
Standard Deviation 1.99
|
-3.44 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=103 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity
Baseline
|
2.62 units on a scale
Standard Deviation 1.47
|
2.71 units on a scale
Standard Deviation 1.56
|
|
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity
Change from Baseline
|
-0.21 units on a scale
Standard Deviation 1.28
|
-0.70 units on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score
Baseline
|
7.64 units on a scale
Standard Deviation 1.45
|
7.60 units on a scale
Standard Deviation 1.38
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score
Change from Baseline
|
-2.15 units on a scale
Standard Deviation 2.17
|
-3.17 units on a scale
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score
Baseline
|
5.09 units on a scale
Standard Deviation 2.00
|
5.07 units on a scale
Standard Deviation 2.12
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score
Change from Baseline
|
-1.60 units on a scale
Standard Deviation 2.13
|
-2.30 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
A self-reported scale that measures the severity of pain based on the average 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 |
Placebo
n=116 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score
Baseline
|
6.25 units on a scale
Standard Deviation 1.55
|
6.19 units on a scale
Standard Deviation 1.59
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score
Change from Baseline
|
-1.77 units on a scale
Standard Deviation 2.19
|
-2.71 units on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score
Baseline
|
6.02 units on a scale
Standard Deviation 2.17
|
5.77 units on a scale
Standard Deviation 2.14
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score
Change from Baseline
|
-2.26 units on a scale
Standard Deviation 2.83
|
-2.94 units on a scale
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity
Baseline
|
5.55 units on a scale
Standard Deviation 2.23
|
5.50 units on a scale
Standard Deviation 2.43
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity
Change from Baseline
|
-1.97 units on a scale
Standard Deviation 2.72
|
-2.63 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood
Change from Baseline
|
-1.69 units on a scale
Standard Deviation 2.66
|
-1.95 units on a scale
Standard Deviation 2.54
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood
Baseline
|
4.22 units on a scale
Standard Deviation 2.74
|
4.06 units on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability
Baseline
|
6.00 units on a scale
Standard Deviation 2.29
|
5.72 units on a scale
Standard Deviation 2.26
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability
Change from Baseline
|
-2.36 units on a scale
Standard Deviation 2.73
|
-2.80 units on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work
Baseline
|
5.80 units on a scale
Standard Deviation 2.08
|
5.63 units on a scale
Standard Deviation 2.32
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work
Change from Baseline
|
-2.25 units on a scale
Standard Deviation 2.48
|
-2.66 units on a scale
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People
Baseline
|
3.27 units on a scale
Standard Deviation 2.82
|
3.05 units on a scale
Standard Deviation 2.81
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People
Change from Baseline
|
-1.30 units on a scale
Standard Deviation 2.48
|
-1.43 units on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep
Baseline
|
4.16 units on a scale
Standard Deviation 2.98
|
4.23 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep
Change from Baseline
|
-1.57 units on a scale
Standard Deviation 2.87
|
-2.18 units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life
Baseline
|
4.04 units on a scale
Standard Deviation 2.89
|
4.42 units on a scale
Standard Deviation 3.06
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life
Change from Baseline
|
-1.39 units on a scale
Standard Deviation 2.89
|
-2.38 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=104 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference
Change from Baseline
|
-1.79 units on a scale
Standard Deviation 2.10
|
-2.29 units on a scale
Standard Deviation 2.18
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference
Baseline
|
4.72 units on a scale
Standard Deviation 2.08
|
4.66 units on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Over 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Placebo
n=119 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=108 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings
|
53 participants who responded
|
64 participants who responded
|
SECONDARY outcome
Timeframe: Over 13 WeeksPopulation: Number of re-randomized patients with non-missing response values.
Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.
Outcome measures
| Measure |
Placebo
n=45 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=42 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase
|
26 participants who responded
|
32 participants who responded
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.
Outcome measures
| Measure |
Placebo
n=113 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=103 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary
Baseline
|
56.58 units on a scale
Standard Deviation 10.38
|
56.43 units on a scale
Standard Deviation 10.36
|
|
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary
Change from Baseline
|
-1.03 units on a scale
Standard Deviation 9.34
|
1.06 units on a scale
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.
Outcome measures
| Measure |
Placebo
n=113 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=103 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
Baseline
|
30.57 units on a scale
Standard Deviation 8.13
|
31.56 units on a scale
Standard Deviation 8.90
|
|
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
Change from Baseline
|
6.36 units on a scale
Standard Deviation 9.24
|
7.71 units on a scale
Standard Deviation 8.61
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.
Outcome measures
| Measure |
Placebo
n=114 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=103 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score
Baseline
|
0.70 units on a scale
Standard Deviation 0.16
|
0.68 units on a scale
Standard Deviation 0.18
|
|
Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score
Change from Baseline
|
0.07 units on a scale
Standard Deviation 0.16
|
0.14 units on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score
Baseline
|
5.64 units on a scale
Standard Deviation 5.89
|
5.49 units on a scale
Standard Deviation 6.84
|
|
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score
Change from Baseline
|
-0.97 units on a scale
Standard Deviation 4.34
|
-1.26 units on a scale
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
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 |
Placebo
n=112 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=101 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Baseline
|
5.36 units on a scale
Standard Deviation 3.86
|
4.59 units on a scale
Standard Deviation 4.02
|
|
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Change from Baseline
|
-0.93 units on a scale
Standard Deviation 2.58
|
-1.15 units on a scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.
Outcome measures
| Measure |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase
Baseline
|
76.97 Units/Liter
Standard Deviation 21.75
|
78.59 Units/Liter
Standard Deviation 20.83
|
|
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase
Change from Baseline
|
-1.94 Units/Liter
Standard Deviation 10.54
|
2.08 Units/Liter
Standard Deviation 12.95
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Change from baseline to endpoint in uric acid using central laboratory reference ranges.
Outcome measures
| Measure |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid
Baseline
|
314.57 micromole/Liter
Standard Deviation 77.12
|
322.77 micromole/Liter
Standard Deviation 95.86
|
|
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid
Change from Baseline
|
6.82 micromole/Liter
Standard Deviation 48.99
|
-5.00 micromole/Liter
Standard Deviation 47.90
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Pulse rate (heart rate) measured in the sitting position.
Outcome measures
| Measure |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate
Baseline
|
70.07 beats per minute
Standard Deviation 8.32
|
69.75 beats per minute
Standard Deviation 8.33
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate
Change from Baseline
|
1.26 beats per minute
Standard Deviation 7.52
|
2.02 beats per minute
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Diastolic blood pressure measured in the sitting position.
Outcome measures
| Measure |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic
Baseline
|
76.44 mm Hg
Standard Deviation 9.78
|
77.00 mm Hg
Standard Deviation 8.82
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic
Change from Baseline
|
-0.38 mm Hg
Standard Deviation 8.73
|
0.95 mm Hg
Standard Deviation 8.46
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Systolic blood pressure measured in the sitting position.
Outcome measures
| Measure |
Placebo
n=117 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic
Baseline
|
129.42 mm Hg
Standard Deviation 14.44
|
128.27 mm Hg
Standard Deviation 14.39
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic
Change from Baseline
|
-2.29 mm Hg
Standard Deviation 12.35
|
1.04 mm Hg
Standard Deviation 14.02
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.
Outcome measures
| Measure |
Placebo
n=118 Participants
placebo daily (QD), by mouth (PO) for 13 weeks
|
Duloxetine 60mg /120mg
n=107 Participants
Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Baseline
|
85.56 kilograms
Standard Deviation 15.14
|
85.39 kilograms
Standard Deviation 16.25
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Change from Baseline
|
-0.33 kilograms
Standard Deviation 2.24
|
-0.79 kilograms
Standard Deviation 2.70
|
Adverse Events
Placebo
Duloxetine 60/120 mg QD
Serious adverse events
| Measure |
Placebo
Placebo
|
Duloxetine 60/120 mg QD
Duloxetine 60/120 mg QD
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Bronchitis
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
Other adverse events
| Measure |
Placebo
Placebo
|
Duloxetine 60/120 mg QD
Duloxetine 60/120 mg QD
|
|---|---|---|
|
Psychiatric disorders
Disorientation
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.7%
2/120 • Number of events 3
|
2.7%
3/111 • Number of events 5
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/120
|
3.6%
4/111 • Number of events 4
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/120
|
2.7%
3/111 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/120
|
1.8%
2/111 • Number of events 2
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Psychiatric disorders
Mood altered
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Psychiatric disorders
Tearfulness
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Palpitations
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Ear and labyrinth disorders
Ear pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Endocrine disorders
Hyperthyroidism
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Eye disorders
Vision blurred
|
0.00%
0/120
|
1.8%
2/111 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/120 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/120
|
3.6%
4/111 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/120 • Number of events 3
|
4.5%
5/111 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
2/120 • Number of events 2
|
1.8%
2/111 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/120
|
1.8%
2/111 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/120 • Number of events 2
|
6.3%
7/111 • Number of events 7
|
|
Gastrointestinal disorders
Stomatitis
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Asthenia
|
0.00%
0/120
|
1.8%
2/111 • Number of events 3
|
|
General disorders
Chest pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Chills
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Condition aggravated
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Fatigue
|
0.83%
1/120 • Number of events 1
|
6.3%
7/111 • Number of events 8
|
|
General disorders
Oedema peripheral
|
0.83%
1/120 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
|
General disorders
Pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
General disorders
Pyrexia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Swelling
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Hepatobiliary disorders
Biliary colic
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Immune system disorders
Hypersensitivity
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Infections and infestations
Cellulitis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Fungal infection
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Influenza
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Molluscum contagiosum
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/120 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Viral infection
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
1/120 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Investigations
Blood creatine phosphokinase increased
|
0.83%
1/120 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Investigations
Blood phosphorus decreased
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Investigations
Blood pressure increased
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Investigations
Blood uric acid increased
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Investigations
Weight decreased
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.83%
1/120 • Number of events 1
|
2.7%
3/111 • Number of events 3
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
3/120 • Number of events 3
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
2/120 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.83%
1/120 • Number of events 3
|
0.00%
0/111
|
|
Nervous system disorders
Diabetic neuropathy
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.7%
2/120 • Number of events 3
|
3.6%
4/111 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.83%
1/120 • Number of events 1
|
2.7%
3/111 • Number of events 3
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
2/120 • Number of events 2
|
0.00%
0/111
|
|
Nervous system disorders
Judgement impaired
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Migraine
|
1.7%
2/120 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Serotonin syndrome
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Sinus headache
|
0.83%
1/120 • Number of events 2
|
0.00%
0/111
|
|
Nervous system disorders
Somnolence
|
0.83%
1/120 • Number of events 1
|
4.5%
5/111 • Number of events 5
|
|
Psychiatric disorders
Agitation
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Apathy
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.83%
1/120 • Number of events 2
|
0.00%
0/111
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.83%
1/120 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Surgical and medical procedures
Nail operation
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Surgical and medical procedures
Oral surgery
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Hot flush
|
0.83%
1/120 • Number of events 1
|
0.00%
0/111
|
|
Vascular disorders
Hypertension
|
0.83%
1/120 • Number of events 1
|
3.6%
4/111 • Number of events 4
|
|
Vascular disorders
Hypotension
|
0.00%
0/120
|
0.90%
1/111 • Number of events 1
|
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