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

NCT ID: NCT00568035

Last Updated: 2009-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

QR-333

Group Type ACTIVE_COMPARATOR

QR-333

Intervention Type DRUG

QR-333 or placebo will be applied three times a day for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

QR-333

Intervention Type DRUG

QR-333 or placebo will be applied three times a day for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QR-333

QR-333 or placebo will be applied three times a day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Quigley Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Richard Rosenbloom

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Raskin, MD

Role: STUDY_CHAIR

University of Texas, Southwestern Medical Center at Dallas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Parkway Medical Center

Birmingham, Alabama, United States

Site Status

Seale Harris Clinic / Alliance Clinical Research

Birmingham, Alabama, United States

Site Status

Pacific Sleep Medicine Services, Inc

Fountain Valley, California, United States

Site Status

Advanced Medical Research, LLC

Lakewood, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Baptist Clinical Research

Pensacola, Florida, United States

Site Status

Stedman Clinical Trails

Tampa, Florida, United States

Site Status

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Site Status

A&A Pain Institute

St Louis, Missouri, United States

Site Status

Rwjms/Umdnj

New Brunswick, New Jersey, United States

Site Status

Land Clinical Studies

West Caldwell, New Jersey, United States

Site Status

Kaleida Health, Diabetes Center of WNY

Buffalo, New York, United States

Site Status

ECU Diabetes Research Center, Brody School of Medicine

Greenville, North Carolina, United States

Site Status

Hartwell Research Group / Anderson Family Care

Anderson, South Carolina, United States

Site Status

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

dgd Research

San Antonio, Texas, United States

Site Status

Endeavor Clinical Trials, PA

San Antonio, Texas, United States

Site Status

Rainier Clinical Research Center, Inc

Renton, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QR-333-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.