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NCT00619983 · ClinicalTrials.gov registry record · Phase 4
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
A Phase 4 study, sponsored by Wake Forest University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT00619983: Clinical Trial Phase 4 study, sponsored by Wake Forest University.
NCT00619983 is a Phase 4 study that was terminated before completion, run by Wake Forest University. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619983, a Phase 4 study, was terminated before completion, sponsored by Wake Forest University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).
Primary Outcome
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
Interventions
- DRUG placebo
- DRUG duloxetine
- DRUG gabapentin
- DRUG donepezil
- DRUG donepezil 2.5 mg and duloxetine 30mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
Why NCT00619983 stopped before completion
NCT00619983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00619983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00619983 about?
NCT00619983 is a clinical study titled "Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy". The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).
What is the current status of trial NCT00619983?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2008-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00619983?
The interventions under investigation include: placebo (DRUG), duloxetine (DRUG), gabapentin (DRUG), donepezil (DRUG), donepezil 2.5 mg and duloxetine 30mg (DRUG).
Who is sponsoring clinical trial NCT00619983?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00619983's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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