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NCT02643251 · ClinicalTrials.gov registry record · Phase 2
The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy
A Phase 2 study of Neuropathy and Diabetic Neuropathy, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT02643251: Completed Phase 2 study of Neuropathy and Diabetic Neuropathy, sponsored by BioDelivery Sciences International.
NCT02643251 is a Phase 2 study of Neuropathy and Diabetic Neuropathy that has completed, run by BioDelivery Sciences International. The registered enrollment target is 138 participants, below the 180-participant average among 22 other Neuropathy trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02643251, a Phase 2 study of Neuropathy and Diabetic Neuropathy, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator.
Primary Outcome
The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 \[±3 days\]) in the Numeric Pain Rating Scale score assessing the "average pain in the past 24 hours in the painful areas of the feet" averaged over Days 78 to 84 compared to the
Conditions Studied
Interventions
- DRUG Clonidine Hydrochloride Topical Gel, 0.1%
- DRUG Clonidine Hydrochloride Gel Comparator
Study Locations (20)
California
- - Anaheim
- - Norco
- - Sacramento
- - Santa Monica
- - Tustin
Florida
- - Fort Myers
- - Ocala
- - Orlando
- - Tampa
- - West Palm Beach
Arizona
- - Glendale
- - Phoenix
- - Phoenix
Illinois
- - Belleville
- - Blue Island
- - Chicago
Idaho
- - Blackfoot
- - Boise
Missouri
- - Hazelwood
Ohio
- - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT02643251 record still lists
NCT02643251 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 180-participant average among 22 other Neuropathy trials with a reported enrollment target (23% lower).
The record links to 3 conditions, with Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Clonidine Hydrochloride Topical Gel, 0.1% is the first listed.
NCT02643251 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02643251 about?
NCT02643251 is a clinical study titled "The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy". The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS) during the Treatment Pha...
What is the current status of trial NCT02643251?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2015-12. Estimated completion is 2016-11.
What conditions does trial NCT02643251 study?
This clinical trial studies the following conditions: Neuropathy, Diabetic Neuropathy, Painful Diabetic Neuropathy.
What interventions are being tested in trial NCT02643251?
The interventions under investigation include: Clonidine Hydrochloride Topical Gel, 0.1% (DRUG), Clonidine Hydrochloride Gel Comparator (DRUG).
Who is sponsoring clinical trial NCT02643251?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02643251 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02643251's enrollment target sits among peer trials
138 11th of 22 higher than 12 of 22 other Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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