Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02355158 · ClinicalTrials.gov registry record · Phase 2
A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy
A Phase 2 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
NCT02355158: Completed Phase 2 study, sponsored by BioDelivery Sciences International.
NCT02355158 is a Phase 2 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02355158, a Phase 2 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
Study Summary
Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner.
Primary Outcome
The NPSI is a validated, self-administered questionnaire designed to evaluate the different symptoms of neuropathic pain. Each item is quantified on an 11-point (0-10) numeric scale. The NPSI includes 10 descriptors (plus 2 temporal items) that allow discrimination and quantification of 5 distinct clinically relevant dimensions of neuropathic pain syndromes. The Neuropathic Pain Symptom Inventory (NPSI) is a self-questionnaire designed to evaluate the different symptoms of neuropathic pain, whic
Interventions
- DRUG clonidine hydrochloride topical gel, 0.1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT02355158 record still lists
NCT02355158 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 1 intervention - of which clonidine hydrochloride topical gel, 0.1% is the first listed.
NCT02355158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02355158 about?
NCT02355158 is a clinical study titled "A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy". Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive activ...
What is the current status of trial NCT02355158?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2014-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02355158?
The interventions under investigation include: clonidine hydrochloride topical gel, 0.1% (DRUG).
Who is sponsoring clinical trial NCT02355158?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02355158's enrollment target sits among peer trials
197 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04219254 · 197 participants · Phase 1
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
- NCT06173778 · 197 participants · Phase 2
Semaglutide for Post-Smoking Cessation Weight Management
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia