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
Phase of Trial: Phase III
Latest Information Update: 09 Dec 2015
At a glance
- Drugs Clonidine (Primary)
- Indications Diabetic neuropathies; Neuropathic pain
- Focus Registrational; Therapeutic Use
- Acronyms RHAPSODY
- Sponsors BioDelivery Sciences International
- 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.