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NCT01533428 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
A Phase 3 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 369
- Enrollment target
NCT01533428: Completed Phase 3 study, sponsored by Astellas Pharma.
NCT01533428 is a Phase 3 study that has completed, run by Astellas Pharma. The registered enrollment target is 369 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01533428, a Phase 3 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 369 participants
- Enrollment target
Study Summary
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
Primary Outcome
Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Interventions
- DRUG Placebo
- DRUG Capsaicin 8%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01533428 record still lists
NCT01533428 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01533428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01533428 about?
NCT01533428 is a clinical study titled "A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)". The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
What is the current status of trial NCT01533428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 369 participants. The study started on 2012-02. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01533428?
The interventions under investigation include: Placebo (DRUG), Capsaicin 8% (DRUG).
Who is sponsoring clinical trial NCT01533428?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01533428's enrollment target sits among peer trials
369 995th of 2000 higher than 1,005 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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