A MULTICENTER RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM PARALLEL-GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF CLONIDINE HYDROCHLORIDE TOPICAL GEL, 0.1% IN THE TREATMENT OF PAIN ASSOCIATED WITH PAINFUL DIABETIC NEUROPATHY

Trial Profile

A MULTICENTER RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM PARALLEL-GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF CLONIDINE HYDROCHLORIDE TOPICAL GEL, 0.1% IN THE TREATMENT OF PAIN ASSOCIATED WITH PAINFUL DIABETIC NEUROPATHY

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2017

At a glance

  • Drugs Clonidine (Primary)
  • Indications Diabetic neuropathies; Neuropathic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms RHAPSODY
  • Sponsors BioDelivery Sciences International
  • Most Recent Events

    • 17 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 30 Mar 2015 Primary endpoint has not been met (change in average pain score over time), according to a BioDelivery Sciences International media release.
    • 16 Mar 2015 According to a BioDelivery Sciences International media release, if top-line results are positive, a regulatory submission is anticipated to occur in the EU during the second half of 2015.
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