Trial Outcomes & Findings for Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China (NCT NCT00408993)
NCT ID: NCT00408993
Last Updated: 2011-07-26
Results Overview
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
215 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2011-07-26
Participant Flow
Participant milestones
| Measure |
Duloxetine
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
Placebo every day (QD), by mouth (PO) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
109
|
|
Overall Study
COMPLETED
|
87
|
92
|
|
Overall Study
NOT COMPLETED
|
19
|
17
|
Reasons for withdrawal
| Measure |
Duloxetine
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
Placebo every day (QD), by mouth (PO) for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
4
|
|
Overall Study
Protocol Violation
|
1
|
6
|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
Baseline characteristics by cohort
| Measure |
Duloxetine
n=106 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.59 years
STANDARD_DEVIATION 10.37 • n=5 Participants
|
59.90 years
STANDARD_DEVIATION 9.52 • n=7 Participants
|
59.25 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
106 participants
n=5 Participants
|
109 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Major Depressive Disorder
No
|
89 participants
n=5 Participants
|
88 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Major Depressive Disorder
Yes
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
106 participants
n=5 Participants
|
109 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Type of Diabetes Mellitus
Type I Diabetes Mellitus
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Type of Diabetes Mellitus
Type II Diabetes Mellitus
|
103 participants
n=5 Participants
|
107 participants
n=7 Participants
|
210 participants
n=5 Participants
|
|
Beck Depression Inventory-II Total Score
|
15.97 units on a scale
STANDARD_DEVIATION 10.66 • n=5 Participants
|
15.27 units on a scale
STANDARD_DEVIATION 11.49 • n=7 Participants
|
15.61 units on a scale
STANDARD_DEVIATION 11.07 • n=5 Participants
|
|
Brief Pain Inventory 24-Hour Average Pain Score
|
5.47 units on a scale
STANDARD_DEVIATION 1.31 • n=5 Participants
|
5.52 units on a scale
STANDARD_DEVIATION 1.39 • n=7 Participants
|
5.50 units on a scale
STANDARD_DEVIATION 1.35 • n=5 Participants
|
|
Clinical Global Impressions of Severity Score
|
4.26 units on a scale
STANDARD_DEVIATION 0.76 • n=5 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 0.91 • n=7 Participants
|
4.32 units on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
Diabetic Neuropathy History
Duration of Diabetes
|
9.07 years
STANDARD_DEVIATION 6.32 • n=5 Participants
|
10.21 years
STANDARD_DEVIATION 6.91 • n=7 Participants
|
9.65 years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
|
Diabetic Neuropathy History
Duration of Diabetic Neuropathy
|
2.13 years
STANDARD_DEVIATION 2.60 • n=5 Participants
|
2.50 years
STANDARD_DEVIATION 2.98 • n=7 Participants
|
2.32 years
STANDARD_DEVIATION 2.80 • n=5 Participants
|
|
Diabetic Neuropathy History
Duration of Diabetic Peripheral Neuropathic Pain
|
3.09 years
STANDARD_DEVIATION 3.11 • n=5 Participants
|
3.34 years
STANDARD_DEVIATION 3.36 • n=7 Participants
|
3.22 years
STANDARD_DEVIATION 3.24 • n=5 Participants
|
|
Height
|
162.64 centimeters
STANDARD_DEVIATION 7.72 • n=5 Participants
|
162.12 centimeters
STANDARD_DEVIATION 7.96 • n=7 Participants
|
162.37 centimeters
STANDARD_DEVIATION 7.83 • n=5 Participants
|
|
Michigan Neuropathy Screening Instrument
|
4.45 units on a scale
STANDARD_DEVIATION 1.19 • n=5 Participants
|
4.59 units on a scale
STANDARD_DEVIATION 1.19 • n=7 Participants
|
4.52 units on a scale
STANDARD_DEVIATION 1.19 • n=5 Participants
|
|
Weight
|
64.06 kilograms
STANDARD_DEVIATION 10.62 • n=5 Participants
|
63.25 kilograms
STANDARD_DEVIATION 11.52 • n=7 Participants
|
63.65 kilograms
STANDARD_DEVIATION 11.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the severity of pain based on the average pain 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
n=104 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
|
-2.69 units on a scale
Standard Error 0.19
|
-2.31 units on a scale
Standard Error 0.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).
Outcome measures
| Measure |
Duloxetine
n=104 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Worst Pain Score
|
-3.48 units on a scale
Standard Error 0.27
|
-2.93 units on a scale
Standard Error 0.26
|
—
|
—
|
|
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Least Pain Score
|
-1.69 units on a scale
Standard Error 0.20
|
-1.37 units on a scale
Standard Error 0.20
|
—
|
—
|
|
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Pain Right Now Score
|
-2.72 units on a scale
Standard Error 0.26
|
-1.99 units on a scale
Standard Error 0.25
|
—
|
—
|
|
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Average Interference Score
|
-2.28 units on a scale
Standard Error 0.21
|
-1.88 units on a scale
Standard Error 0.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Outcome measures
| Measure |
Duloxetine
n=103 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity
|
-1.24 units on a scale
Standard Error 0.11
|
-0.99 units on a scale
Standard Error 0.11
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, over 12 weeksPopulation: Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.
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
n=98 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=107 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Time Course of Change in Patient Global Impression - Improvement Scale
Week 1 (N=5, N=2)
|
3.45 units on a scale
Standard Error 0.56
|
3.51 units on a scale
Standard Error 0.88
|
—
|
—
|
|
Time Course of Change in Patient Global Impression - Improvement Scale
Week 2 (N=98, N=107)
|
2.91 units on a scale
Standard Error 0.09
|
3.23 units on a scale
Standard Error 0.09
|
—
|
—
|
|
Time Course of Change in Patient Global Impression - Improvement Scale
Week 4 (N=94, N=101)
|
2.57 units on a scale
Standard Error 0.10
|
2.83 units on a scale
Standard Error 0.10
|
—
|
—
|
|
Time Course of Change in Patient Global Impression - Improvement Scale
Week 8 (N=91, N=95)
|
2.29 units on a scale
Standard Error 0.11
|
2.76 units on a scale
Standard Error 0.11
|
—
|
—
|
|
Time Course of Change in Patient Global Impression - Improvement Scale
Week 12 (N=87, N=92)
|
2.27 units on a scale
Standard Error 0.11
|
2.58 units on a scale
Standard Error 0.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
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 |
Duloxetine
n=101 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=101 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)
|
0.12 units on a scale
Standard Error 0.02
|
0.10 units on a scale
Standard Error 0.02
|
—
|
—
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: Intention to Treat Analysis. All randomized patients.
Outcome measures
| Measure |
Duloxetine
n=106 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants Discontinuing Due to Adverse Events
|
15 participants
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: Number of randomized patients in each treatment arm for each dosing group
Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.
Outcome measures
| Measure |
Duloxetine
n=53 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=53 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
n=56 Participants
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
n=53 Participants
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Abdominal discomfort
|
3 participants
|
1 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Abdominal distension
|
7 participants
|
2 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Abdominal pain upper
|
0 participants
|
4 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Anorexia
|
4 participants
|
7 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Arthralgia
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Asthenia
|
2 participants
|
4 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Chest discomfort
|
2 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Constipation
|
4 participants
|
7 participants
|
5 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Cough
|
2 participants
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Decreased appetite
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Diarrhoea
|
4 participants
|
6 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Dizziness
|
5 participants
|
11 participants
|
9 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Dry mouth
|
2 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Dyslipidaemia
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Dysuria
|
5 participants
|
4 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Fatigue
|
3 participants
|
5 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Headache
|
4 participants
|
2 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Hyperhidrosis
|
4 participants
|
5 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Hypersomnia
|
0 participants
|
2 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Hypoglycaemia
|
5 participants
|
5 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Insomnia
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Lethargy
|
6 participants
|
5 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Nausea
|
14 participants
|
18 participants
|
8 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Pain
|
1 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Palpitations
|
7 participants
|
3 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Pruritus
|
2 participants
|
1 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Somnolence
|
9 participants
|
8 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Stomach discomfort
|
4 participants
|
3 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Therapeutic response unexpected
|
6 participants
|
3 participants
|
6 participants
|
6 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Thirst
|
4 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Vomiting
|
3 participants
|
3 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
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 (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.
Outcome measures
| Measure |
Duloxetine
n=103 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item
5-Item Score
|
-2.27 units on a scale
Standard Error 0.31
|
-1.97 units on a scale
Standard Error 0.29
|
—
|
—
|
|
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item
8-Item Score
|
-3.58 units on a scale
Standard Error 0.47
|
-3.31 units on a scale
Standard Error 0.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Change from baseline to endpoint in body weight.
Outcome measures
| Measure |
Duloxetine
n=104 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Vital Signs - Weight
|
-0.17 kilograms
Standard Error 0.21
|
-0.03 kilograms
Standard Error 0.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Change from baseline to endpoint in pulse rate.
Outcome measures
| Measure |
Duloxetine
n=104 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Vital Signs - Pulse Rate
|
1.71 beats per minute
Standard Error 1.06
|
0.32 beats per minute
Standard Error 1.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Change from baseline to endpoint in systolic and diastolic blood pressure.
Outcome measures
| Measure |
Duloxetine
n=104 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=109 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Vital Signs - Blood Pressure
Systolic Blood Pressure
|
-0.48 mm Hg
Standard Error 1.61
|
-1.47 mm Hg
Standard Error 1.56
|
—
|
—
|
|
Vital Signs - Blood Pressure
Diastolic Blood Pressure
|
0.45 mm Hg
Standard Error 0.95
|
-0.21 mm Hg
Standard Error 0.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.
Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.
Outcome measures
| Measure |
Duloxetine
n=99 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=104 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Chloride Baseline
|
102.94 millimole/Liter
Standard Deviation 3.07
|
102.87 millimole/Liter
Standard Deviation 2.99
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Chloride Change to Endpoint
|
-1.15 millimole/Liter
Standard Deviation 3.60
|
-0.20 millimole/Liter
Standard Deviation 2.81
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
High Density Lipoprotein Cholesterol Baseline
|
1.30 millimole/Liter
Standard Deviation 0.37
|
1.33 millimole/Liter
Standard Deviation 0.33
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
High Density Lipoprotein Change to Endpoint
|
0.03 millimole/Liter
Standard Deviation 0.22
|
-0.04 millimole/Liter
Standard Deviation 0.19
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Sodium Baseline
|
143.03 millimole/Liter
Standard Deviation 2.83
|
142.76 millimole/Liter
Standard Deviation 3.00
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Sodium Change to Endpoint
|
-1.25 millimole/Liter
Standard Deviation 3.64
|
-0.19 millimole/Liter
Standard Deviation 2.72
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Triglycerides Baseline
|
1.76 millimole/Liter
Standard Deviation 1.48
|
1.40 millimole/Liter
Standard Deviation 0.76
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Triglycerides Change to Endpoint
|
-0.05 millimole/Liter
Standard Deviation 1.07
|
0.26 millimole/Liter
Standard Deviation 1.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.
Significantly different laboratory values between the two groups in baseline to endpoint changes
Outcome measures
| Measure |
Duloxetine
n=99 Participants
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
|
Placebo
n=104 Participants
Placebo every day (QD), by mouth (PO) for 12 weeks
|
Placebo - Morning Dosing
Placebo QD, PO for 12 weeks
|
Placebo - Evening Dosing
Placebo QD, PO for 12 weeks
|
|---|---|---|---|---|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid
Uric Acid Baseline
|
293.24 micromole/Liter
Standard Deviation 72.51
|
283.98 micromole/Liter
Standard Deviation 75.88
|
—
|
—
|
|
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid
Uric Acid Change to Endpoint
|
-7.46 micromole/Liter
Standard Deviation 62.19
|
2.49 micromole/Liter
Standard Deviation 53.29
|
—
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
Duloxetine 60/120 mg QD
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
Placebo
|
Duloxetine 60/120 mg QD
Duloxetine 60/120 mg QD
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/109
|
0.94%
1/106 • Number of events 1
|
|
Cardiac disorders
Cardiac failure acute
|
0.92%
1/109 • Number of events 1
|
0.00%
0/106
|
|
Gastrointestinal disorders
Nausea
|
0.92%
1/109 • Number of events 1
|
0.94%
1/106 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
1/109 • Number of events 1
|
0.94%
1/106 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/109
|
0.94%
1/106 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.92%
1/109 • Number of events 1
|
0.00%
0/106
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/109
|
0.94%
1/106 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/109
|
0.94%
1/106 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/109
|
0.94%
1/106 • Number of events 1
|
Other adverse events
| Measure |
Placebo
Placebo
|
Duloxetine 60/120 mg QD
Duloxetine 60/120 mg QD
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
4.6%
5/109 • Number of events 6
|
9.4%
10/106 • Number of events 11
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.5%
6/109 • Number of events 6
|
3.8%
4/106 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
7/109 • Number of events 7
|
8.5%
9/106 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
8.3%
9/109 • Number of events 10
|
11.3%
12/106 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
6/109 • Number of events 6
|
10.4%
11/106 • Number of events 11
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
3/109 • Number of events 3
|
5.7%
6/106 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
11.0%
12/109 • Number of events 15
|
29.2%
31/106 • Number of events 33
|
|
Gastrointestinal disorders
Stomach discomfort
|
4.6%
5/109 • Number of events 6
|
6.6%
7/106 • Number of events 7
|
|
General disorders
Asthenia
|
0.92%
1/109 • Number of events 1
|
5.7%
6/106 • Number of events 6
|
|
General disorders
Fatigue
|
7.3%
8/109 • Number of events 8
|
7.5%
8/106 • Number of events 8
|
|
General disorders
Therapeutic response unexpected
|
11.0%
12/109 • Number of events 18
|
8.5%
9/106 • Number of events 15
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
2/109 • Number of events 2
|
10.4%
11/106 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.5%
6/109 • Number of events 7
|
9.4%
10/106 • Number of events 10
|
|
Nervous system disorders
Dizziness
|
11.0%
12/109 • Number of events 12
|
15.1%
16/106 • Number of events 19
|
|
Nervous system disorders
Headache
|
5.5%
6/109 • Number of events 8
|
5.7%
6/106 • Number of events 6
|
|
Nervous system disorders
Lethargy
|
3.7%
4/109 • Number of events 4
|
10.4%
11/106 • Number of events 12
|
|
Nervous system disorders
Somnolence
|
5.5%
6/109 • Number of events 6
|
16.0%
17/106 • Number of events 18
|
|
Renal and urinary disorders
Dysuria
|
0.92%
1/109 • Number of events 1
|
8.5%
9/106 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
3/109 • Number of events 3
|
8.5%
9/106 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
8/109 • Number of events 8
|
2.8%
3/106 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60