Trial Outcomes & Findings for Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy (NCT NCT00619983)
NCT ID: NCT00619983
Last Updated: 2018-09-11
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Study completion (16 weeks)
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
Donepezil
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Duloxetine
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Donepezil + Duloxetine
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
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
|---|---|---|---|---|
|
Test Drug Alone
STARTED
|
5
|
5
|
6
|
6
|
|
Test Drug Alone
COMPLETED
|
3
|
4
|
4
|
3
|
|
Test Drug Alone
NOT COMPLETED
|
2
|
1
|
2
|
3
|
|
Test Drug Plus Gabapentin
STARTED
|
3
|
4
|
4
|
3
|
|
Test Drug Plus Gabapentin
COMPLETED
|
3
|
4
|
4
|
3
|
|
Test Drug Plus Gabapentin
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Gabapentin Alone
STARTED
|
3
|
4
|
4
|
3
|
|
Gabapentin Alone
COMPLETED
|
3
|
4
|
4
|
3
|
|
Gabapentin Alone
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Donepezil
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Duloxetine
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Donepezil + Duloxetine
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
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
|---|---|---|---|---|
|
Test Drug Alone
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Test Drug Alone
Failure of daily diary device
|
1
|
1
|
2
|
2
|
Baseline Characteristics
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Donepezil
n=5 Participants
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Duloxetine
n=5 Participants
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Donepezil + Duloxetine
n=6 Participants
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
n=6 Participants
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
56 years
n=7 Participants
|
59 years
n=5 Participants
|
70 years
n=4 Participants
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Study completion (16 weeks)Population: 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
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).
Outcome measures
| Measure |
Donepezil
n=3 Participants
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Duloxetine
n=4 Participants
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Donepezil + Duloxetine
n=4 Participants
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
n=3 Participants
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
|---|---|---|---|---|
|
Visual Analog Scale for Pain
Baseilne ( weeks)
|
3.3 units on a scale
Interval 2.0 to 6.7
|
6.4 units on a scale
Interval 2.3 to 9.8
|
5.8 units on a scale
Interval 3.6 to 7.3
|
4.9 units on a scale
Interval 4.5 to 8.4
|
|
Visual Analog Scale for Pain
Test drug alone (6 weeks)
|
4.1 units on a scale
Interval 1.5 to 4.6
|
2.9 units on a scale
Interval 1.6 to 9.7
|
5.2 units on a scale
Interval 4.3 to 6.9
|
3.9 units on a scale
Interval 2.4 to 4.8
|
|
Visual Analog Scale for Pain
Drug plus gabapentin (6 weeks)
|
2.9 units on a scale
Interval 0.4 to 3.2
|
2.7 units on a scale
Interval 1.1 to 9.7
|
3.9 units on a scale
Interval 3.5 to 5.3
|
4.1 units on a scale
Interval 1.1 to 6.3
|
|
Visual Analog Scale for Pain
Gabapentin alone (2 weeks)
|
2.2 units on a scale
Interval 0.0 to 2.6
|
3.0 units on a scale
Interval 2.4 to 10.0
|
4.3 units on a scale
Interval 3.3 to 5.2
|
4.1 units on a scale
Interval 1.9 to 6.4
|
Adverse Events
Donepezil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Duloxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Donepezil + Duloxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donepezil
n=5 participants at risk
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Duloxetine
n=5 participants at risk
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Donepezil + Duloxetine
n=6 participants at risk
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
n=6 participants at risk
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina
|
0.00%
0/5 • During the 16 week study
|
0.00%
0/5 • During the 16 week study
|
0.00%
0/6 • During the 16 week study
|
16.7%
1/6 • Number of events 1 • During the 16 week study
|
Other adverse events
| Measure |
Donepezil
n=5 participants at risk
Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Duloxetine
n=5 participants at risk
Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
Donepezil + Duloxetine
n=6 participants at risk
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
n=6 participants at risk
Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/5 • During the 16 week study
|
0.00%
0/5 • During the 16 week study
|
0.00%
0/6 • During the 16 week study
|
16.7%
1/6 • Number of events 1 • During the 16 week study
|
|
Infections and infestations
osteomyelitis
|
20.0%
1/5 • Number of events 1 • During the 16 week study
|
0.00%
0/5 • During the 16 week study
|
0.00%
0/6 • During the 16 week study
|
0.00%
0/6 • During the 16 week study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place