Clinical trial NCT00568035: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathy
Keywords: diabetic
peripheral
neuropathy
Lead sponsor: Quigley Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Determine the safety of a three times daily application of QR-333 as compared to placebo.
timeFrame: 12 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Seale Harris Clinic / Alliance Clinical Research
state: Alabama
city: Fountain Valley
country: United States
facility: Pacific Sleep Medicine Services, Inc
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research, LLC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pensacola
country: United States
facility: Baptist Clinical Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trails
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: St. Louis
country: United States
facility: A&A Pain Institute
state: Missouri
city: New Brunswick
country: United States
facility: Rwjms/Umdnj
state: New Jersey
city: West Caldwell
country: United States
facility: Land Clinical Studies
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Health, Diabetes Center of WNY
state: New York
city: Greenville
country: United States
facility: ECU Diabetes Research Center, Brody School of Medicine
state: North Carolina
city: Anderson
country: United States
facility: Hartwell Research Group / Anderson Family Care
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: San Antonio
country: United States
facility: dgd Research
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc
state: Washington
Study officials:
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Philip Raskin, MD
role: STUDY_CHAIR
References: