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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02643251
The ClinicalTrials.gov registry entry for NCT02643251 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 180-participant average among 22 other Neuropathy trials with a reported enrollment target (23% lower). The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.