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

January 7, 2009 updated by: Quigley Pharma, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Birmingham, Alabama, United States, 35216
        • Seale Harris Clinic / Alliance Clinical Research
    • California
      • Fountain Valley, California, United States, 92708
        • Pacific Sleep Medicine Services, Inc
      • Lakewood, California, United States, 90712
        • Advanced Medical Research, LLC
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Pensacola, Florida, United States, 35201
        • Baptist Clinical Research
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trails
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • A&A Pain Institute
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rwjms/Umdnj
      • West Caldwell, New Jersey, United States, 07006
        • Land Clinical Studies
    • New York
      • Buffalo, New York, United States, 14209
        • Kaleida Health, Diabetes Center of WNY
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Diabetes Research Center, Brody School of Medicine
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Hartwell Research Group / Anderson Family Care
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials, PA
      • San Antonio, Texas, United States, 78229
        • DGD Research
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: QR-333
QR-333 or placebo will be applied three times a day for 12 weeks
ACTIVE_COMPARATOR: QR-333
Drug: QR-333
QR-333 or placebo will be applied three times a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the safety of a three times daily application of QR-333 as compared to placebo.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quigley Pharma, Inc.

Investigators

  • Study Chair: Philip Raskin, MD, University of Texas, Southwestern Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (ESTIMATE)

December 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2009

Last Update Submitted That Met QC Criteria

January 7, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QR-333-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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