Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 3, 2007

Last Updated Date

January 7, 2009

Start Date ^†

December 2006

Current Primary Outcome Measures ^†

Determine the safety of a three times daily application of QR-333 as compared to placebo. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00568035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Determine the efficacy of QR-333 on symptoms of diabetic neuropathy and the impact of QR-333 on the daily activities (including pain and sleep disturbance) of subjects with symptomatic diabetic neuropathy as compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy

Official Title ^†

Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy

Brief Summary

The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.

Detailed Description

Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.

To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).

The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as compared to placebo.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetic Neuropathy

Intervention ^†

Drug: QR-333

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

140

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

diagnosis of diabetic neuropathy
must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment
must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed

Exclusion Criteria:

uncontrolled pain that has persisted for > 12 months.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00568035

Responsible Party

Quigley Pharma, Inc., Richard Rosenbloom

Secondary IDs ^††

Study Sponsor ^†

Quigley Pharma, Inc.

Collaborators ^††

Investigators ^†

Study Chair:

Philip Raskin, MD

University of Texas Southwestern Medical Center at Dallas

Information Provided By

Quigley Pharma, Inc.

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.