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NCT02068027 · ClinicalTrials.gov registry record · Phase 2

Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy

A Phase 2 study, sponsored by BioDelivery Sciences International.

Completed
Registry status
Phase 2
Development phase
260
Enrollment target

NCT02068027: Completed Phase 2 study, sponsored by BioDelivery Sciences International.

NCT02068027 is a Phase 2 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 260 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02068027, a Phase 2 study, has completed, sponsored by BioDelivery Sciences International.

COMPLETED
Registry status
Phase 2
Development phase
260 participants
Enrollment target

Study Summary

The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.

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

Interventions

  • DRUG Placebo
  • DRUG Clonidine Gel 0.1%

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2014-03
Est. Completion 2015-03
Phase Phase 2
BioDelivery Sciences International

17 total trials

What the finished NCT02068027 record still lists

NCT02068027 is an interventional study that assigns participants to a tested intervention. The registered 260 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 (95% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02068027 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02068027 about?

NCT02068027 is a clinical study titled "Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy". The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.

What is the current status of trial NCT02068027?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2014-03. Estimated completion is 2015-03.

What interventions are being tested in trial NCT02068027?

The interventions under investigation include: Placebo (DRUG), Clonidine Gel 0.1% (DRUG).

Who is sponsoring clinical trial NCT02068027?

This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02068027's enrollment target sits among peer trials

260 210th of 2000 higher than 1,789 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

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Source: ClinicalTrials.gov NCT02068027, the US trial registry maintained by the National Library of Medicine. NCT02068027 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.