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Trial record 69 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

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ClinicalTrials.gov Identifier: NCT00322621
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : December 18, 2009
Last Update Posted : February 7, 2011
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Neuropathies
Intervention Drug: Duloxetine
Enrollment 216
Recruitment Details  
Pre-assignment Details Study Period I was a 5-9 day Screening Phase. Study Period II was an 8 week Acute Therapy Phase. Study Period III was a 26 week Maintenance and Rescue Therapy Phase. Study Period IV was a 2 week Taper Phase.
Arm/Group Title Acute Phase Maintenance Arm Rescue Arm
Hide Arm/Group Description All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Duloxetine: 60 milligrams once daily. Duloxetine: 120 milligrams once daily.
Period Title: Period II - Acute Therapy Phase
Started 216 0 0
Completed 184 0 0
Not Completed 32 0 0
Reason Not Completed
Adverse Event             20             0             0
Lack of Efficacy             1             0             0
Withdrawal by Subject             8             0             0
Protocol Violation             2             0             0
Physician Decision             1             0             0
Period Title: Period III - Maintenance / Rescue Phase
Started 0 115 69
Completed 0 86 33
Not Completed 0 29 36
Reason Not Completed
Adverse Event             0             14             5
Lack of Efficacy             0             4             24
Withdrawal by Subject             0             7             1
Protocol Violation             0             2             5
Death             0             1             0
Lost to Follow-up             0             1             1
Arm/Group Title Acute Phase
Hide Arm/Group Description All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
Overall Number of Baseline Participants 216
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants
63.3  (9.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
Female
104
  48.1%
Male
112
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
France 43
Brazil 66
Germany 66
Italy 41
Duration of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
<=2 years 78
>2 years 138
Duration of Neuropathic Pain  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
<=1 year 38
>1 year 178
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
Caucasian 173
West Asian 33
African 6
Hispanic 4
Type of Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
Type 1 12
Type 2 204
Brief Pain Inventory 24-Hour Average Pain Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 216 participants
5.88  (1.45)
[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).
Height at Visit 1 (Week -1)  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 216 participants
166.7  (10.39)
Weight at Visit 2 (Week 0)  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 216 participants
84.0  (18.36)
1.Primary Outcome
Title Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
Hide Description Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is 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 (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.35  (2.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.
Statistical Test of Hypothesis P-Value <0.001
Comments Significance level 0.025
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.35
Confidence Interval 97.5%
0.35 to 0.79
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
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 (Week 0), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
76
3.Secondary Outcome
Title Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
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 (Week 0), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
21
4.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.29  (2.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.33  (2.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.24  (1.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.93  (3.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.35  (2.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.39  (2.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.48  (2.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.12  (3.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.22  (2.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
Hide Description A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.01  (3.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.39  (2.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.29  (3.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.59  (3.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.15  (3.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.63  (2.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.97  (3.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.13  (2.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.12  (3.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.10  (2.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.84  (3.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
24.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.11  (3.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.711
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.19  (3.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.678
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
26.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.28  (2.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
27.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.59  (3.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
28.Secondary Outcome
Title Maintenance Arm: Patient’s Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
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 Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.32  (1.33)
29.Secondary Outcome
Title Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
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 Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.04  (1.32)
30.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.11  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
31.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
Hide Description 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).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.46  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
32.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
Hide Description This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.31  (7.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
33.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
Hide Description This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.38  (7.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
34.Secondary Outcome
Title Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
Hide 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.
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Maintenance Arm
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.82  (5.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
35.Secondary Outcome
Title Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
Hide 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.
Time Frame Baseline (Week 8), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Arm/Group Title Rescue Arm
Hide Arm/Group Description:
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.53  (6.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rescue Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
36.Secondary Outcome
Title Number of Participants Discontinuing in the Acute Phase
Hide Description [Not Specified]
Time Frame Baseline (Week 0) to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Acute Phase (through Week 8).
Arm/Group Title Acute Phase
Hide Arm/Group Description:
All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
Overall Number of Participants Analyzed 216
Measure Type: Number
Unit of Measure: participants
Initiating at Week 0 216
Continuing at Week 1 201
Continuing at Week 8 184
37.Secondary Outcome
Title Number of Participants Discontinuing in Maintenance / Rescue Phase
Hide Description [Not Specified]
Time Frame Baseline (Week 8) to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)
Arm/Group Title All Maintenance / Rescue Participants Maintenance Arm (No Dose Increase) Maintenance Arm (Later Dose Increase) Rescue Arm
Hide Arm/Group Description:
Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily.
duloxetine 60 mg once daily
duloxetine 60 mg once daily and then increasing to 120 mg once daily
duloxetine 120 mg once daily
Overall Number of Participants Analyzed 184 103 12 69
Measure Type: Number
Unit of Measure: participants
Entering at Week 8 184 103 12 69
Continuing at Week 12 171 96 12 63
Continuing at Week 16 142 92 11 39
Continuing at Week 24 128 84 10 34
Completing at Week 34 119 77 9 33
38.Secondary Outcome
Title Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint
Hide Description [Not Specified]
Time Frame Baseline (Week 0), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received either 60 mg or 120 mg duloxetine once daily.
Arm/Group Title Duloxetine 60 mg Duloxetine 120 mg
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 214 80
Mean (Standard Deviation)
Unit of Measure: beats per minute
2.4  (10.78) 0.4  (11.46)
39.Secondary Outcome
Title Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint
Hide Description [Not Specified]
Time Frame Baseline (Week 0), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received either 60 mg or 120 mg duloxetine once daily.
Arm/Group Title Duloxetine 60 mg Duloxetine 120 mg
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 214 80
Mean (Standard Deviation)
Unit of Measure: mm Hg
-0.1  (9.39) -1.0  (9.18)
40.Secondary Outcome
Title Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint
Hide Description [Not Specified]
Time Frame Baseline (Week 0), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received either 60 mg or 120 mg duloxetine once daily.
Arm/Group Title Duloxetine 60 mg Duloxetine 120 mg
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 214 80
Mean (Standard Deviation)
Unit of Measure: mm Hg
-4.2  (14.94) 0.7  (15.27)
41.Secondary Outcome
Title Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint
Hide Description [Not Specified]
Time Frame Baseline (Week 0), Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received either 60 mg or 120 mg duloxetine once daily.
Arm/Group Title Duloxetine 60 mg Duloxetine 120 mg
Hide Arm/Group Description:
Duloxetine: 60 milligrams once daily
Duloxetine: 120 milligrams once daily
Overall Number of Participants Analyzed 214 80
Mean (Standard Deviation)
Unit of Measure: kilograms (kg)
-1.3  (4.17) 0.2  (3.16)
Time Frame 34 Weeks
Adverse Event Reporting Description There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
 
Arm/Group Title Duloxetine 60 mg Duloxetine 120 mg
Hide Arm/Group Description Duloxetine: 60 milligrams once daily Duloxetine: 120 milligrams once daily
All-Cause Mortality
Duloxetine 60 mg Duloxetine 120 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine 60 mg Duloxetine 120 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/216 (8.33%)      2/81 (2.47%)    
Cardiac disorders     
Angina unstable  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Atrial fibrillation  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Cardiac failure congestive  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Eye disorders     
Cataract  1  2/216 (0.93%)  2 0/81 (0.00%)  0
Gastrointestinal disorders     
Intestinal ischaemia  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Oesophageal ulcer haemorrhage  1  1/216 (0.46%)  1 0/81 (0.00%)  0
General disorders     
Chest pain  1  2/216 (0.93%)  2 0/81 (0.00%)  0
Sudden death  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Infections and infestations     
Viral labyrinthitis  1  0/216 (0.00%)  0 1/81 (1.23%)  1
Injury, poisoning and procedural complications     
Rib fracture  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Diabetic ketoacidosis  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Hypokalaemia  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Nervous system disorders     
Syncope  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Transient ischaemic attack  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Psychiatric disorders     
Suicidal ideation  1  0/216 (0.00%)  0 1/81 (1.23%)  1
Renal and urinary disorders     
Anuria  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Urinary retention  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders     
Diabetic neuropathic ulcer  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Pruritus  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Vascular disorders     
Peripheral arterial occlusive disease  1  1/216 (0.46%)  1 0/81 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Duloxetine 60 mg Duloxetine 120 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   135/216 (62.50%)      40/81 (49.38%)    
Ear and labyrinth disorders     
Vertigo  1  9/216 (4.17%)  9 2/81 (2.47%)  2
Gastrointestinal disorders     
Abdominal pain upper  1  5/216 (2.31%)  7 4/81 (4.94%)  4
Constipation  1  9/216 (4.17%)  9 1/81 (1.23%)  1
Diarrhoea  1  7/216 (3.24%)  9 7/81 (8.64%)  9
Dry mouth  1  13/216 (6.02%)  13 1/81 (1.23%)  1
Nausea  1  41/216 (18.98%)  46 3/81 (3.70%)  3
Vomiting  1  7/216 (3.24%)  7 2/81 (2.47%)  2
General disorders     
Asthenia  1  11/216 (5.09%)  12 1/81 (1.23%)  1
Chills  1  7/216 (3.24%)  8 0/81 (0.00%)  0
Fatigue  1  11/216 (5.09%)  18 0/81 (0.00%)  0
Infections and infestations     
Influenza  1  5/216 (2.31%)  5 0/81 (0.00%)  0
Nasopharyngitis  1  5/216 (2.31%)  5 1/81 (1.23%)  1
Injury, poisoning and procedural complications     
Excoriation  1  0/216 (0.00%)  0 2/81 (2.47%)  2
Metabolism and nutrition disorders     
Anorexia  1  12/216 (5.56%)  12 0/81 (0.00%)  0
Decreased appetite  1  6/216 (2.78%)  7 0/81 (0.00%)  0
Diabetic foot  1  1/216 (0.46%)  1 2/81 (2.47%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/216 (1.39%)  4 2/81 (2.47%)  2
Back pain  1  8/216 (3.70%)  9 0/81 (0.00%)  0
Muscle spasms  1  6/216 (2.78%)  15 0/81 (0.00%)  0
Pain in extremity  1  7/216 (3.24%)  12 2/81 (2.47%)  2
Nervous system disorders     
Dizziness  1  7/216 (3.24%)  9 1/81 (1.23%)  1
Headache  1  11/216 (5.09%)  24 3/81 (3.70%)  3
Somnolence  1  18/216 (8.33%)  19 3/81 (3.70%)  3
Psychiatric disorders     
Insomnia  1  6/216 (2.78%)  6 1/81 (1.23%)  3
Reproductive system and breast disorders     
Erectile dysfunction  1  7/216 (3.24%)  7 0/81 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  14/216 (6.48%)  16 1/81 (1.23%)  1
Vascular disorders     
Arteriosclerosis  1  1/216 (0.46%)  1 2/81 (2.47%)  2
Hypertension  1  4/216 (1.85%)  4 2/81 (2.47%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 1-800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00322621     History of Changes
Other Study ID Numbers: 10258
F1J-MC-HMEM ( Other Identifier: Eli Lilly and Company )
First Submitted: May 5, 2006
First Posted: May 8, 2006
Results First Submitted: October 30, 2008
Results First Posted: December 18, 2009
Last Update Posted: February 7, 2011