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

Sponsored by:	Quigley Pharma, Inc.
Information provided by:	Quigley Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00568035

Purpose

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.

Condition	Intervention	Phase
Diabetic Neuropathy	Drug: QR-333	Phase II

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy

Further study details as provided by Quigley Pharma, Inc.:

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 ]

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 ]

Estimated Enrollment:	140
Study Start Date:	December 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
QR-333: Active Comparator	Drug: QR-333 QR-333 or placebo will be applied three times a day for 12 weeks
Placebo: Placebo Comparator	Drug: QR-333 QR-333 or placebo will be applied three times a day for 12 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568035

Locations

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

Sponsors and Collaborators

Quigley Pharma, Inc.

Investigators

Study Chair:

Philip Raskin, MD

University of Texas Southwestern Medical Center at Dallas

More Information

Responsible Party:	Richard Rosenbloom ( Quigley Pharma, Inc. )
Study ID Numbers:	QR-333-002
Study First Received:	December 3, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00568035
Health Authority:	United States: Food and Drug Administration

Keywords provided by Quigley Pharma, Inc.:

diabetic
peripheral
neuropathy

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009