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NCT06495424 · ClinicalTrials.gov registry record
Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy
A clinical trial of Painful Diabetic Neuropathy and Peripheral Diabetic Neuropathy, sponsored by Averitas Pharma.
- Recruiting
- Registry status
- 150
- Enrollment target
- 14
- Study locations
NCT06495424: Recruiting study of Painful Diabetic Neuropathy and Peripheral Diabetic Neuropathy, sponsored by Averitas Pharma.
NCT06495424 is a study of Painful Diabetic Neuropathy and Peripheral Diabetic Neuropathy that is actively recruiting participants, run by Averitas Pharma. The registered enrollment target is 150 participants, above the 102-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (47% higher). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06495424, a study of Painful Diabetic Neuropathy and Peripheral Diabetic Neuropathy, is actively recruiting participants, sponsored by Averitas Pharma.
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.
Primary Outcome
The pain intensity score from baseline will be compared to the average weekly pain intensity score between weeks 2-12 post each QUTENZA application (up to 3 applications).
Conditions Studied
Interventions
- DRUG Capsaicin 8%
Study Locations (14)
California
- Pacific Research Institute - Lakeport
- Pacific Research Institute - Santa Rosa
- Pacific Research Institute - Santa Rosa
- Pacific Research Institute - Sonoma
Georgia
- Horizon Clinical Research - Gainesville
- Horizon Clinical Research - Jasper
- Horizon Clinical Research - Newnan
Pennsylvania
- Center for Interventional Pain and Spine - Bryn Mawr
- Center for Interventional Pain and Spine - Fort Washington
- Center for Interventional Pain and Spine - Lancaster
Delaware
- Center for Interventional Pain and Spine - Wilmington
Kentucky
- Iqra Research - Edgewood
New Jersey
- Curalta Clinical Trials - Oradell
Ohio
- Iqra Research - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-03-14 |
| Est. Completion | 2027-03 |
What NCT06495424 shows while recruiting
NCT06495424 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (47% higher).
The record links to 2 conditions, with Painful Diabetic Neuropathy appearing as the primary indexed condition, and to 1 intervention - of which Capsaicin 8% is the first listed.
NCT06495424 lists 14 locations in 7 states (California, Georgia, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06495424 about?
NCT06495424 is a clinical study titled "Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy". The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.
What is the current status of trial NCT06495424?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2025-03-14. Estimated completion is 2027-03.
What conditions does trial NCT06495424 study?
This clinical trial studies the following conditions: Painful Diabetic Neuropathy, Peripheral Diabetic Neuropathy.
What interventions are being tested in trial NCT06495424?
The interventions under investigation include: Capsaicin 8% (DRUG).
Who is sponsoring clinical trial NCT06495424?
This trial is sponsored by Averitas Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06495424 being conducted?
This trial has 14 study locations across California, Delaware, Georgia, Kentucky, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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