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Trial record 8 of 8 for:    "Neuropathy, Painful" | "Serotonin and Noradrenaline Reuptake Inhibitors"

Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00619983
Recruitment Status : Terminated (Study terminated due to low enrollment)
First Posted : February 21, 2008
Results First Posted : August 10, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetic Neuropathic Pain
Chronic Low Back Pain
Interventions Drug: donepezil
Drug: duloxetine
Drug: donepezil 2.5 mg and duloxetine 30mg
Drug: placebo
Drug: gabapentin
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil Duloxetine Donepezil + Duloxetine Placebo
Hide Arm/Group Description Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
Period Title: Test Drug Alone
Started 5 5 6 6
Completed 3 4 4 3
Not Completed 2 1 2 3
Reason Not Completed
Withdrawal by Subject             1             0             0             1
Failure of daily diary device             1             1             2             2
Period Title: Test Drug Plus Gabapentin
Started 3 4 4 3
Completed 3 4 4 3
Not Completed 0 0 0 0
Period Title: Gabapentin Alone
Started 3 4 4 3
Completed 3 4 4 3
Not Completed 0 0 0 0
Arm/Group Title Donepezil Duloxetine Donepezil + Duloxetine Placebo Total
Hide Arm/Group Description Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Total of all reporting groups
Overall Number of Baseline Participants 5 5 6 6 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
62
(52 to 65)
56
(54 to 60)
59
(58 to 59)
70
(65 to 72)
60
(50 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
Female
4
  80.0%
0
   0.0%
1
  16.7%
3
  50.0%
8
  36.4%
Male
1
  20.0%
5
 100.0%
5
  83.3%
3
  50.0%
14
  63.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
2
  40.0%
2
  33.3%
1
  16.7%
7
  31.8%
White
3
  60.0%
3
  60.0%
4
  66.7%
5
  83.3%
15
  68.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
5 5 6 6 22
1.Primary Outcome
Title Visual Analog Scale for Pain
Hide Description The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as "No pain at all" and on the right as "The worst pain imaginable". The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone).
Time Frame Study completion (16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
As noted in patient flow, data are available for only 14 of 22 subjects due to failure of the electronic daily diaries used to assess pain during the study and to study discontinuation in some cases
Arm/Group Title Donepezil Duloxetine Donepezil + Duloxetine Placebo
Hide Arm/Group Description:
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
Overall Number of Participants Analyzed 3 4 4 3
Median (Full Range)
Unit of Measure: units on a scale
Baseilne ( weeks)
3.3
(2.0 to 6.7)
6.4
(2.3 to 9.8)
5.8
(3.6 to 7.3)
4.9
(4.5 to 8.4)
Test drug alone (6 weeks)
4.1
(1.5 to 4.6)
2.9
(1.6 to 9.7)
5.2
(4.3 to 6.9)
3.9
(2.4 to 4.8)
Drug plus gabapentin (6 weeks)
2.9
(0.4 to 3.2)
2.7
(1.1 to 9.7)
3.9
(3.5 to 5.3)
4.1
(1.1 to 6.3)
Gabapentin alone (2 weeks)
2.2
(0 to 2.6)
3.0
(2.4 to 10)
4.3
(3.3 to 5.2)
4.1
(1.9 to 6.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil, Duloxetine, Donepezil + Duloxetine, Placebo
Comments Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit < 30% of the number of subjects required in our power analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Time Frame During the 16 week study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil Duloxetine Donepezil + Duloxetine Placebo
Hide Arm/Group Description Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15. Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
All-Cause Mortality
Donepezil Duloxetine Donepezil + Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/5 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Duloxetine Donepezil + Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)      0/6 (0.00%)      1/6 (16.67%)    
Cardiac disorders         
Angina * [1]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subject experienced chest pain and was hospitalized. Serial ECGs and troponins were negative for myocardial injury
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Donepezil Duloxetine Donepezil + Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/5 (0.00%)      0/6 (0.00%)      1/6 (16.67%)    
Gastrointestinal disorders         
nausea  [1]  0/5 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations         
osteomyelitis  [2]  1/5 (20.00%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
subject experienced nausea
[2]
subject experienced osteomyelitis of of second phalange
We recruited only a small proportion of the planned enrollment in the period of grant funding, leading to early termination of the study. Also, the failure of the electronic diaries and loss of primary outcome data prevented the planned analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. James Eisenach
Organization: Wake Forest School of Medicine
Phone: 336-716-4182
EMail: jimeisenach@gmail.com
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00619983     History of Changes
Other Study ID Numbers: IRB00003943
5R01NS057594 ( U.S. NIH Grant/Contract )
First Submitted: February 8, 2008
First Posted: February 21, 2008
Results First Submitted: July 11, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 11, 2018