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Combination Pain Therapy in HIV Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00863057
Recruitment Status : Terminated (Due to slow rate of enrollment, which compromised the ability to meet study objectives in a timely manner.)
First Posted : March 17, 2009
Results First Posted : April 25, 2012
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions HIV Infections
Peripheral Neuropathy
Interventions Drug: Duloxetine
Drug: Duloxetine placebo
Drug: Methadone
Drug: Methadone placebo
Enrollment 15
Recruitment Details Participants were recruited across 8 of 15 study sites in the AIDS Clinical Trials Group system between August 2009 and October 2010. The sites were: Harbor-UCLA Medical Center, Harvard MGH, Houston AIDS Research Team, Metrohealth Medical Center in Cleveland, Northwestern University, UC San Diego Medical Center, Washington Univ., Univ. of Colorado.
Pre-assignment Details  
Arm/Group Title D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P
Hide Arm/Group Description

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Period Title: Milestones Period 1 (Weeks 0-5)
Started 4 4 3 4
Completed 3 2 3 3
Not Completed 1 2 0 1
Reason Not Completed
Adverse Event             1             1             0             1
Physician Decision             0             1             0             0
Period Title: Period 2 (Weeks 6-10)
Started 3 2 3 3
Completed 3 1 2 2
Not Completed 0 1 1 1
Reason Not Completed
Adverse Event             0             1             1             0
Physician Decision             0             0             0             1
Period Title: Period 3 (Weeks 11-15)
Started 3 1 2 2
Completed 3 1 2 2
Not Completed 0 0 0 0
Period Title: Period 4 (Weeks 16-20)
Started 3 1 2 2
Completed 3 1 2 2
Not Completed 0 0 0 0
Arm/Group Title D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P Total
Hide Arm/Group Description

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Total of all reporting groups
Overall Number of Baseline Participants 4 4 3 4 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
20-29 0 0 0 1 1
30-39 0 1 0 0 1
40-49 0 0 1 1 2
50-59 3 2 1 2 8
>= 60 1 1 1 0 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
Female
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
2
  13.3%
Male
4
 100.0%
4
 100.0%
1
  33.3%
4
 100.0%
13
  86.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
White/Caucasian 1 3 1 2 7
Black/African American 2 1 1 1 5
Hispanic/Latino 1 0 1 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
4 4 3 4 15
Baseline CD4 Counts  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
400  (278) 522  (328) 867  (162) 249  (173) 486  (315)
Baseline CD8 Counts  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
970  (639) 490  (205) 1042.33  (1110) 794.75  (534) 809.73  (618)
Baseline Log10(HIV RNA Viral Load) in copies/mL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
<= 1.70 2 3 3 2 10
=1.71 0 0 0 1 1
=2.19 1 0 0 0 1
=2.34 1 0 0 0 1
=4.61 0 1 0 0 1
=5.90 0 0 0 1 1
Baseline Daily Mean Pain Intensity (MPI) Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
7.8  (0.5) 6.5  (1.3) 6  (1) 7.3  (2.2) 6.9  (1.4)
[1]
Measure Description: Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=“No pain” to 10=“Pain as bad as you can imagine”.Participants were given diary at weeks 0, 5, 10, and 15. They started diary 7 days prior to their clinic visits at 0,4,9,14,19. Each day, recorded a number from 0 to 10. These numbers were averaged by the number of days so the total range of scores is still from 0 to 10.
Baseline Night Time Mean Pain Intensity (MPI) Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
7.3  (1.0) 6.8  (1.0) 7.3  (1.2) 8  (1.4) 7.3  (1.1)
[1]
Measure Description: Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=“No pain” to 10=“Pain as bad as you can imagine”.Participants were given diary at weeks 0, 5, 10, and 15. They started diary 7 days prior to their clinic visits at 0,4,9,14,19. Each day, recorded a number from 0 to 10. These numbers were averaged by the number of days so the total range of scores is still from 0 to 10.
Baseline Brief Pain Inventory (BPI) Interference Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
5.6  (1.1) 4.1  (0.5) 4.5  (2.8) 6.1  (3.7) 5.1  (2.3)
[1]
Measure Description:

The BPI interference scale measured level of interference with the following seven items:

  1. General activity
  2. Mood
  3. Walking ability
  4. Normal work
  5. Relations with other people
  6. Sleep
  7. Enjoyment of life

Interference scales range from 0=’Does not interfere’ to 10=’Completely interferes’. The overall BPI score is the mean of seven items.

Baseline Center for Epidemiologic Studies Depression (CES-D) Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
13  (10) 11  (8) 9  (9) 16  (22) 12  (13)
[1]
Measure Description:

The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item:(0)Rarely,(1)Occasionally,(2)Sometimes,(3)Most of time.Some items are multiplied by -1 to change direction.

The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered.

1.Primary Outcome
Title Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale
Hide Description

Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain" to 10=``Pain as bad as you can imagine".

Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours.

Time Frame During the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
5.20  (2.44) 5.91  (2.47) 6.20  (2.35) 5.70  (2.16)
2.Secondary Outcome
Title Number of Participants With 30% or More Improvement in Mean Pain Score on an 11-point Likert Scale
Hide Description

Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain" to 10=``Pain as bad as you can imagine" at baseline and over the fourth treatment week of each treatment period.

The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage.

Time Frame At Baseline and over the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Measure Type: Number
Unit of Measure: participants
2 2 2 2
3.Secondary Outcome
Title Number of Participants With 50% or More Improvement in Mean Pain Score on an 11-point Likert Scale
Hide Description

Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain" to 10=``Pain as bad as you can imagine" at baseline and over the fourth treatment week of each treatment period.

The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage.

Time Frame At Baseline and over the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Measure Type: Number
Unit of Measure: participants
2 2 1 2
4.Secondary Outcome
Title Mean Nighttime Pain Measure on an 11-point Likert Scale
Hide Description

Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain" to 10=``Pain as bad as you can imagine".

Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time.

Time Frame Over the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Mean (Standard Error)
Unit of Measure: Scores on a scale
5.20  (2.35) 5.82  (2.27) 5.90  (2.33) 6.10  (2.47)
5.Secondary Outcome
Title Pain-related Interference Measured by the Brief Pain Inventory (BPI) Interference Items
Hide Description

The BPI interference scale measured level of interference with the following seven items:

  1. General activity
  2. Mood
  3. Walking ability
  4. Normal work
  5. Relations with other people
  6. Sleep
  7. Enjoyment of life

Interference scales range from 0=’Does not interfere’ to 10=’Completely interferes’. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively.

Time Frame At the fourth week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
3.14
(2.57 to 4.57)
4.14
(2.29 to 7.14)
3.64
(3.29 to 6.71)
3.14
(2.57 to 5.57)
6.Secondary Outcome
Title Quality of Life Measured by SF-36 Healthy Survey (SF-36)
Hide Description The data for this outcome are not available for the analysis due to an issue with a company which provides software to calculate SF-36.
Time Frame At the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Emotional Functioning as Measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Hide Description The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered.
Time Frame At the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
13.8  (10.9) 13.8  (14.5) 13.3  (10.8) 13.3  (13.2)
8.Secondary Outcome
Title Patient and Clinician Global Impression of Change (PGIC and CGIC) on a 7-point Likert Scale
Hide Description

The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse

Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study.

Time Frame At the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Measure Type: Number
Unit of Measure: participants
PGIC - Very much improved 1 0 1 1
PGIC - Much improved 4 1 2 1
PGIC - Minimally improved 2 4 4 4
PGIC - No change 3 6 2 4
PGIC - Much worse 0 0 1 0
CGIC - Very much improved 1 1 1 1
CGIC - Much improved 4 1 3 1
CGIC - Minimally improved 1 1 3 3
CGIC - No change 4 8 3 4
CGIC - Much worse 0 0 0 1
9.Secondary Outcome
Title Use of Rescue Medication (Acetaminophen)
Hide Description [Not Specified]
Time Frame During each treatment period and the subsequent cross-over (or final study week) period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Because of a cross-over trial, the # of participants analyzed do not match with the flow chart. Any participant who took the rescue med during the study period (incl. cross-over period) was counted in this analysis. If a participant took the rescue med twice within the same period, the number is counted as one.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Measure Type: Number
Unit of Measure: participants
Treatment period (1-4, 6-9, 11-14, 16-19 weeks) 0 0 0 2
Cross-over period (5, 10, 15, 20 weeks) 1 0 1 1
10.Secondary Outcome
Title Maximum Tolerated Dose of Duloxetine and Methadone
Hide Description [Not Specified]
Time Frame During each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The number below is the highest tolerated daily dose in mg based on n=12 for Methadone and n=10 for Duloxetine.
Arm/Group Title Methadone Duloxetine
Hide Arm/Group Description:
Maximum tolerated daily dose of Methadone was reported.
Maximum tolerated daily dose of Duloxetine was reported.
Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: mg
30 60
11.Secondary Outcome
Title Number of Participants With Treatment-emergent Grade 2 to 4 Adverse Events
Hide Description The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 was used (see the link to the grading table in Protocol Section)
Time Frame From study entry to end of study at week 20 or premature study discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description:
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
Overall Number of Participants Analyzed 10 11 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
4
  36.4%
6
  60.0%
5
  50.0%
12.Other Pre-specified Outcome
Title Sensory and Affective Qualities of Pain Measured by the McGill Pain Questionnaire - Short Form (MPQ-SF)
Hide Description This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint in the future.
Time Frame At the fourth treatment week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
This was one of the exploratory objectives and was not analyzed as the study was terminated.
Arm/Group Title D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P
Hide Arm/Group Description:

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Other Pre-specified Outcome
Title Methadone Trough Level and Weekly Mean Pain Scores
Hide Description This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint.
Time Frame During the fourth week of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
This was one of the exploratory objectives and was not analyzed as the study was terminated.
Arm/Group Title D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P
Hide Arm/Group Description:

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo

Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Through out the study period. Participants were followed for the duration of study period, which is 20 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Hide Arm/Group Description Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments. Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments. Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments. Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
All-Cause Mortality
Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/11 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine and Methadone Duloxetine and Methadone Placebo Duloxetine Placebo and Methadone Duloxetine Placebo and Methadone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      4/11 (36.36%)      6/10 (60.00%)      5/10 (50.00%)    
Blood and lymphatic system disorders         
Total Bilirubin  1  2/10 (20.00%)  2 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Ear and labyrinth disorders         
Ear Abnormality  1  0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Eye disorders         
Diplopia  1  0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders         
Constipation  1  1/10 (10.00%)  1 0/11 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0
Diarrhoea  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Dry mouth  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nausea  1  2/10 (20.00%)  2 1/11 (9.09%)  1 2/10 (20.00%)  2 0/10 (0.00%)  0
Vomiting  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Cramp  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Congestion  1  0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders         
Fatigue  1  3/10 (30.00%)  3 0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Malaise  1  2/10 (20.00%)  2 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pain  1  0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1
Ache  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Hepatobiliary disorders         
Sgot  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Alkaline Phosphatase  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders         
Dizziness  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Headache  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Cognition, Abnormal  1  0/10 (0.00%)  0 0/1 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders         
Anxiety  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Depression  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Agitation  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Insomnia  1  2/8 (25.00%)  2 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Dreams, Abnormal  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Mental Status Change, Psychiatric  1  0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Renal and urinary disorders         
Urinary retention  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Creatinine  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
The results should be interpreted with caution since the total sample size was much lower than planned.
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00863057     History of Changes
Other Study ID Numbers: A5252
10636 ( Registry Identifier: DAIDS ES )
ACTG A5252
First Submitted: March 16, 2009
First Posted: March 17, 2009
Results First Submitted: December 14, 2011
Results First Posted: April 25, 2012
Last Update Posted: February 18, 2019