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NCT00603265 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A Phase 2 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
NCT00603265: Completed Phase 2 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT00603265 is a Phase 2 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 226 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00603265, a Phase 2 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are thought to be due to damage to nerves caused by the diabetes.
Primary Outcome
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicat
Interventions
- DRUG Placebo
- DRUG Duloxetine
- DRUG ADL5859
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
What the finished NCT00603265 record still lists
NCT00603265 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00603265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00603265 about?
NCT00603265 is a clinical study titled "Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy". The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are thought to be due to damage ...
What is the current status of trial NCT00603265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2007-11. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00603265?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG), ADL5859 (DRUG).
Who is sponsoring clinical trial NCT00603265?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00603265's enrollment target sits among peer trials
226 267th of 2000 higher than 1,734 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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