Loading clinical trials...
Loading clinical trials...
A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy
The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Site: 601
Bonheiden, Belgium
Site: 903
Beroun, Czechia
Site: 910
Brno, Czechia
Site: 908
Choceň, Czechia
Site: 911
Litoměřice, Czechia
Site: 906
Ostrava, Czechia
Site: 904
Polička, Czechia
Site: 901
Prague, Czechia
Site: 902
Přerov, Czechia
Site: 909
Rychnov nad Kněžnou, Czechia
Start Date
November 1, 2011
Primary Completion Date
February 1, 2014
Completion Date
February 1, 2014
Last Updated
October 14, 2015
468
ACTUAL participants
QUTENZA
DRUG
Lead Sponsor
Astellas Pharma Inc
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions