A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA in Subjects With Painful Diabetic Peripheral Neuropathy
Phase of Trial: Phase III
Latest Information Update: 18 Sep 2015
At a glance
- Drugs Capsaicin (Primary)
- Indications Diabetic neuropathies; Neuropathic pain
- Focus Registrational; Therapeutic Use
- Acronyms STEP
- Sponsors Astellas Pharma
- 18 Sep 2015 Based on results from this and a other trial (CTP-207980), the European Commission has granted approval for a label extension for QUTENZA(capsaicin 8% patch) to include the treatment of adult diabetic patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain, according to an Astellas pharma media release.
- 13 Mar 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 18 Dec 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.