A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone 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 Adverse reactions; Registrational
- Acronyms PACE
- Sponsors Astellas Pharma
- 10 Jun 2017 Biomarkers information updated
- 18 Sep 2015 Based on results from this and a other trial (CTP-213583), 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.
- 26 Mar 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.