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NCT01496365 · ClinicalTrials.gov registry record · Phase 2
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A Phase 2 study of Diabetic Peripheral Neuropathy, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 452
- Enrollment target
- 20
- Study locations
NCT01496365: Completed Phase 2 study of Diabetic Peripheral Neuropathy, sponsored by Daiichi Sankyo.
NCT01496365 is a Phase 2 study of Diabetic Peripheral Neuropathy that has completed, run by Daiichi Sankyo. The registered enrollment target is 452 participants, above the 102-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (343% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01496365, a Phase 2 study of Diabetic Peripheral Neuropathy, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 452 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
Primary Outcome
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Conditions Studied
Interventions
- DRUG Placebo tablet
- DRUG placebo capsule
- DRUG DS-5565 tablet
- DRUG pregabalin capsule
Study Locations (20)
California
- - Buena Park
- - Burbank
- - Chino
- - Fresno
- - Huntington Beach
- - Lakewood
- - Lomita
- - Long Beach
- - Santa Monica
- - Walnut Creek
Arizona
- - Mesa
- - Phoenix
- - Phoenix
- - Tucson
Alabama
- - Birmingham
- - Huntsville
Arkansas
- - Hot Springs
- - Little Rock
Colorado
- - Boulder
- - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2011-11-28 |
| Est. Completion | 2012-09-07 |
| Phase | Phase 2 |
What the finished NCT01496365 record still lists
NCT01496365 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (343% higher).
The record links to 1 condition, with Diabetic Peripheral Neuropathy appearing as the primary indexed condition, and to 4 interventions - of which Placebo tablet is the first listed.
NCT01496365 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01496365 about?
NCT01496365 is a clinical study titled "Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy". The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
What is the current status of trial NCT01496365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 452 participants. The study started on 2011-11-28. Estimated completion is 2012-09-07.
What conditions does trial NCT01496365 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy.
What interventions are being tested in trial NCT01496365?
The interventions under investigation include: Placebo tablet (DRUG), placebo capsule (DRUG), DS-5565 tablet (DRUG), pregabalin capsule (DRUG).
Who is sponsoring clinical trial NCT01496365?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01496365 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01496365's enrollment target sits among peer trials
452 2nd of 17 the highest of 17 other Diabetic Peripheral Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Peripheral Neuropathy 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.
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