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NCT00385671 · ClinicalTrials.gov registry record · Phase 4
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 407
- Enrollment target
NCT00385671: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00385671 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 407 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00385671, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 407 participants
- Enrollment target
Study Summary
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.
Primary Outcome
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.
Interventions
- DRUG gabapentin
- DRUG pregabalin
- DRUG duloxetine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
What the finished NCT00385671 record still lists
NCT00385671 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 3 interventions - of which gabapentin is the first listed.
NCT00385671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00385671 about?
NCT00385671 is a clinical study titled "An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain". To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.
What is the current status of trial NCT00385671?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 407 participants. The study started on 2006-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00385671?
The interventions under investigation include: gabapentin (DRUG), pregabalin (DRUG), duloxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00385671?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00385671's enrollment target sits among peer trials
407 208th of 2000 higher than 1,792 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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