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Trial record 68 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

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ClinicalTrials.gov Identifier: NCT00408993
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : June 2, 2009
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Neuropathies
Interventions Drug: Duloxetine Hydrochloride
Drug: Placebo
Enrollment 215
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description 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 every day (QD), by mouth (PO) for 12 weeks
Period Title: Overall Study
Started 106 109
Completed 87 92
Not Completed 19 17
Reason Not Completed
Adverse Event             15             4
Protocol Violation             1             6
Lack of Efficacy             1             4
Withdrawal by Subject             2             3
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description 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 every day (QD), by mouth (PO) for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 106 109 215
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 109 participants 215 participants
58.59  (10.37) 59.90  (9.52) 59.25  (9.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 215 participants
Female
55
  51.9%
59
  54.1%
114
  53.0%
Male
51
  48.1%
50
  45.9%
101
  47.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 106 participants 109 participants 215 participants
106 109 215
Major Depressive Disorder  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 215 participants
No 89 88 177
Yes 17 21 38
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
East Asian Number Analyzed 106 participants 109 participants 215 participants
106 109 215
Type of Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 215 participants
Type I Diabetes Mellitus 3 2 5
Type II Diabetes Mellitus 103 107 210
Beck Depression Inventory-II Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 109 participants 215 participants
15.97  (10.66) 15.27  (11.49) 15.61  (11.07)
[1]
Measure Description: 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.
Brief Pain Inventory 24-Hour Average Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 109 participants 215 participants
5.47  (1.31) 5.52  (1.39) 5.50  (1.35)
[1]
Measure Description: 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).
Clinical Global Impressions of Severity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 109 participants 215 participants
4.26  (0.76) 4.38  (0.91) 4.32  (0.84)
[1]
Measure Description: 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.
Diabetic Neuropathy History  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 109 participants 215 participants
Duration of Diabetes 9.07  (6.32) 10.21  (6.91) 9.65  (6.63)
Duration of Diabetic Neuropathy 2.13  (2.60) 2.50  (2.98) 2.32  (2.80)
Duration of Diabetic Peripheral Neuropathic Pain 3.09  (3.11) 3.34  (3.36) 3.22  (3.24)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 106 participants 109 participants 215 participants
162.64  (7.72) 162.12  (7.96) 162.37  (7.83)
Michigan Neuropathy Screening Instrument   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 109 participants 215 participants
4.45  (1.19) 4.59  (1.19) 4.52  (1.19)
[1]
Measure Description: Assesses degree of neuropathy. Responses to 13 out of 15 items are added to obtain total score. Responses of “yes” to items 1,2,3,5,6,8,9,11,12,14,15 are each counted as one point. A “no” response on items 7 and 13 counts as 1 point. Items 4 and 10 are not included in scoring. Total scores range from 0 (no neuropathy) to 13 (severe neuropathy).
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 106 participants 109 participants 215 participants
64.06  (10.62) 63.25  (11.52) 63.65  (11.07)
1.Primary Outcome
Title Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 104 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.69  (0.19) -2.31  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.
Method ANCOVA
Comments Model=Treatment, Pooled Investigator and Baseline.
2.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 104 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain Score -3.48  (0.27) -2.93  (0.26)
Least Pain Score -1.69  (0.20) -1.37  (0.20)
Pain Right Now Score -2.72  (0.26) -1.99  (0.25)
Average Interference Score -2.28  (0.21) -1.88  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments P-value for Worst Pain Score
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments P-value for Least Pain Score
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value for Pain Right Now Score
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments P-value for Average Interference Score
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
3.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 103 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.24  (0.11) -0.99  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
4.Secondary Outcome
Title Time Course of Change in Patient Global Impression - Improvement Scale
Hide Description 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).
Time Frame baseline, over 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 98 107
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 (N=5, N=2) 3.45  (0.56) 3.51  (0.88)
Week 2 (N=98, N=107) 2.91  (0.09) 3.23  (0.09)
Week 4 (N=94, N=101) 2.57  (0.10) 2.83  (0.10)
Week 8 (N=91, N=95) 2.29  (0.11) 2.76  (0.11)
Week 12 (N=87, N=92) 2.27  (0.11) 2.58  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.955
Comments P-value for Visit 3
Method Mixed Models Analysis
Comments Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value for Visit 4
Method Mixed Models Analysis
Comments Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments P-value for Visit 5
Method Mixed Models Analysis
Comments Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Visit 6
Method Mixed Models Analysis
Comments Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments P-value for Visit 7
Method Mixed Models Analysis
Comments Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.
5.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire – 5 Dimensions (EQ-5D) (US Based Index Score)
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 101 101
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.12  (0.02) 0.10  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.207
Comments [Not Specified]
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
6.Secondary Outcome
Title Number of Participants Discontinuing Due to Adverse Events
Hide Description [Not Specified]
Time Frame over 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat Analysis. All randomized patients.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 106 109
Measure Type: Number
Unit of Measure: participants
15 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Hide Description Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.
Time Frame over 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients in each treatment arm for each dosing group
Arm/Group Title Duloxetine - Morning Dosing Duloxetine - Evening Dosing Placebo - Morning Dosing Placebo - Evening Dosing
Hide Arm/Group Description:
60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
Placebo QD, PO for 12 weeks
Placebo QD, PO for 12 weeks
Overall Number of Participants Analyzed 53 53 56 53
Measure Type: Number
Unit of Measure: participants
Abdominal discomfort 3 1 2 4
Abdominal distension 7 2 4 3
Abdominal pain upper 0 4 2 0
Anorexia 4 7 1 1
Arthralgia 1 0 3 2
Asthenia 2 4 0 1
Chest discomfort 2 3 1 0
Constipation 4 7 5 4
Cough 2 0 4 1
Decreased appetite 0 3 0 1
Diarrhoea 4 6 5 1
Dizziness 5 11 9 3
Dry mouth 2 4 1 2
Dyslipidaemia 1 3 1 1
Dysuria 5 4 0 1
Fatigue 3 5 2 6
Headache 4 2 4 2
Hyperhidrosis 4 5 1 2
Hypersomnia 0 2 2 3
Hypoglycaemia 5 5 3 2
Insomnia 3 2 3 2
Lethargy 6 5 2 2
Nausea 14 18 8 5
Pain 1 1 3 0
Palpitations 7 3 2 3
Pruritus 2 1 4 4
Somnolence 9 8 2 4
Stomach discomfort 4 3 5 0
Therapeutic response unexpected 6 3 6 6
Thirst 4 1 0 1
Vomiting 3 3 2 3
8.Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 103 109
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5-Item Score -2.27  (0.31) -1.97  (0.29)
8-Item Score -3.58  (0.47) -3.31  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.364
Comments P-value for 5-Item Score
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.590
Comments P-value for 8-Item Score
Method ANCOVA
Comments Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.
9.Secondary Outcome
Title Vital Signs - Weight
Hide Description Change from baseline to endpoint in body weight.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 104 109
Least Squares Mean (Standard Error)
Unit of Measure: kilograms
-0.17  (0.21) -0.03  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.620
Comments [Not Specified]
Method ANOVA
Comments Model=Treatment and Pooled Investigator
10.Secondary Outcome
Title Vital Signs - Pulse Rate
Hide Description Change from baseline to endpoint in pulse rate.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 104 109
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
1.71  (1.06) 0.32  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments [Not Specified]
Method ANOVA
Comments Model=Treatment and Pooled Investigator
11.Secondary Outcome
Title Vital Signs - Blood Pressure
Hide Description Change from baseline to endpoint in systolic and diastolic blood pressure.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with a baseline and at least one non-missing post-baseline value.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 104 109
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Systolic Blood Pressure -0.48  (1.61) -1.47  (1.56)
Diastolic Blood Pressure 0.45  (0.95) -0.21  (0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments P-value for Systolic Blood Pressure
Method ANOVA
Comments Model=Treatment and Pooled Investigator
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.601
Comments P-value for Diastolic Blood Pressure
Method ANOVA
Comments Model=Treatment and Pooled Investigator
12.Secondary Outcome
Title Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Hide Description Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 99 104
Mean (Standard Deviation)
Unit of Measure: millimole/Liter
Chloride Baseline 102.94  (3.07) 102.87  (2.99)
Chloride Change to Endpoint -1.15  (3.60) -0.20  (2.81)
High Density Lipoprotein Cholesterol Baseline 1.30  (0.37) 1.33  (0.33)
High Density Lipoprotein Change to Endpoint 0.03  (0.22) -0.04  (0.19)
Sodium Baseline 143.03  (2.83) 142.76  (3.00)
Sodium Change to Endpoint -1.25  (3.64) -0.19  (2.72)
Triglycerides Baseline 1.76  (1.48) 1.40  (0.76)
Triglycerides Change to Endpoint -0.05  (1.07) 0.26  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments P-value for Chloride
Method ANOVA
Comments Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value for High Density Lipoprotein Cholesterol
Method ANOVA
Comments Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value for Sodium
Method ANOVA
Comments Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments P-value for triglycerides
Method ANOVA
Comments Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.
13.Secondary Outcome
Title Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid
Hide Description Significantly different laboratory values between the two groups in baseline to endpoint changes
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:
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 every day (QD), by mouth (PO) for 12 weeks
Overall Number of Participants Analyzed 99 104
Mean (Standard Deviation)
Unit of Measure: micromole/Liter
Uric Acid Baseline 293.24  (72.51) 283.98  (75.88)
Uric Acid Change to Endpoint -7.46  (62.19) 2.49  (53.29)
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Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANOVA
Comments Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Duloxetine 60/120 mg QD
Hide Arm/Group Description Placebo Duloxetine 60/120 mg QD
All-Cause Mortality
Placebo Duloxetine 60/120 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Duloxetine 60/120 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2      2    
Cardiac disorders     
Acute myocardial infarction  1  0/109 (0.00%)  0 1/106 (0.94%)  1
Cardiac failure acute  1  1/109 (0.92%)  1 0/106 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  1/109 (0.92%)  1 1/106 (0.94%)  1
Vomiting  1  1/109 (0.92%)  1 1/106 (0.94%)  1
General disorders     
Death  1  0/109 (0.00%)  0 1/106 (0.94%)  1
Infections and infestations     
Nasopharyngitis  1  1/109 (0.92%)  1 0/106 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  0/109 (0.00%)  0 1/106 (0.94%)  1
Renal and urinary disorders     
Renal impairment  1  0/109 (0.00%)  0 1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  0/109 (0.00%)  0 1/106 (0.94%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Duloxetine 60/120 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77      85    
Cardiac disorders     
Palpitations  1  5/109 (4.59%)  6 10/106 (9.43%)  11
Gastrointestinal disorders     
Abdominal discomfort  1  6/109 (5.50%)  6 4/106 (3.77%)  4
Abdominal distension  1  7/109 (6.42%)  7 9/106 (8.49%)  9
Constipation  1  9/109 (8.26%)  10 12/106 (11.32%)  14
Diarrhoea  1  6/109 (5.50%)  6 11/106 (10.38%)  11
Dry mouth  1  3/109 (2.75%)  3 6/106 (5.66%)  7
Nausea  1  12/109 (11.01%)  15 31/106 (29.25%)  33
Stomach discomfort  1  5/109 (4.59%)  6 7/106 (6.60%)  7
General disorders     
Asthenia  1  1/109 (0.92%)  1 6/106 (5.66%)  6
Fatigue  1  8/109 (7.34%)  8 8/106 (7.55%)  8
Therapeutic response unexpected  1  12/109 (11.01%)  18 9/106 (8.49%)  15
Metabolism and nutrition disorders     
Anorexia  1  2/109 (1.83%)  2 11/106 (10.38%)  11
Hypoglycaemia  1  6/109 (5.50%)  7 10/106 (9.43%)  10
Nervous system disorders     
Dizziness  1  12/109 (11.01%)  12 16/106 (15.09%)  19
Headache  1  6/109 (5.50%)  8 6/106 (5.66%)  6
Lethargy  1  4/109 (3.67%)  4 11/106 (10.38%)  12
Somnolence  1  6/109 (5.50%)  6 17/106 (16.04%)  18
Renal and urinary disorders     
Dysuria  1  1/109 (0.92%)  1 9/106 (8.49%)  9
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  3/109 (2.75%)  3 9/106 (8.49%)  11
Pruritus  1  8/109 (7.34%)  8 3/106 (2.83%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 1-800-545-5979
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00408993     History of Changes
Other Study ID Numbers: 10599
F1J-MC-HMEQ(a) ( Other Identifier: Eli Lilly and Company )
First Submitted: December 6, 2006
First Posted: December 8, 2006
Results First Submitted: February 5, 2009
Results First Posted: June 2, 2009
Last Update Posted: July 26, 2011