Study Details

A study to evaluate efficacy and safety of a single application of Capsaicin 8%transdermal delivery system compared to placebo in reducing pain intensity in subjects with Painful Diabetic Peripheral Neuropathy (PDPN)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01533428

Astellas Study ID

The unique identification code given by the study sponsor.

E05-CL-3004

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Neuropathic Pain, Pain

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Feb 2012 - Feb 2014

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

369

A phase III, double-blind, randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of QUTENZA® in subjects with Painful Diabetic Peripheral Neuropathy

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site: 125

Anniston, United States, 36207

Site: 109

Birmingham, United States, 35216

Site:104

Birmingham, United States, 35216

Site: 131

Fresno, United States, 93720

Site: 123

Long Beach, United States, 90806

Site: 116

Los Angeles, United States, 90033

Site: 112

Orange, United States, 92868

Site: 130

Walnut Creek, United States, 94597

Site: 113

Milford, United States, 06460

Site: 119

New London, United States, 06320

Site: 117

Boynton Beach, United States, 33435

Site: 124

Bradenton, United States, 34205

Site: 107

Clearwater, United States, 33765

Site: 120

Jupiter, United States, 33458

Site: 101

Miramar, United States, 33027

Site: 108

Orlando, United States, 32806

Site: 132

Oviedo, United States, 32765

Site: 127

St. Petersburg, United States, 33709

Site: 122

Tampa, United States, 33606

Site: 133

Honolulu, United States, 96814

Site: 126

New Bedford, United States, 02740

Site: 115

Ann Arbor, United States, 48104

Site: 128

Hazelwood, United States, 63042

Site:111

New York, United States, 10029

Site: 110

Winston-Salem, United States, 27103

Site: 121

Kettering, United States, 45429

Site:106

Dallas, United States, 75230

Site: 114

Houston, United States, 77098

Site: 118

Houston, United States, 77030

Site: 103

Lubbock, United States, 79410

Site: 105

San Antonio, United States, 78228

Site: 102

San Antonio, United States, 78229