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

Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568035
• Other study ID #: QR-333-002
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2007
• Last updated: January 7, 2009
• Start date: December 2006
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: Quigley Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

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

Locations

Country	Name	City	State
United States	Hartwell Research Group / Anderson Family Care	Anderson	South Carolina
United States	Parkway Medical Center	Birmingham	Alabama
United States	Seale Harris Clinic / Alliance Clinical Research	Birmingham	Alabama
United States	Kaleida Health, Diabetes Center of WNY	Buffalo	New York
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Pacific Sleep Medicine Services, Inc	Fountain Valley	California
United States	ECU Diabetes Research Center, Brody School of Medicine	Greenville	North Carolina
United States	Advanced Medical Research, LLC	Lakewood	California
United States	Rwjms/Umdnj	New Brunswick	New Jersey
United States	Renstar Medical Research	Ocala	Florida
United States	Baptist Clinical Research	Pensacola	Florida
United States	Rainier Clinical Research Center, Inc	Renton	Washington
United States	dgd Research	San Antonio	Texas
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	A&A Pain Institute	St. Louis	Missouri
United States	Stedman Clinical Trails	Tampa	Florida
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Land Clinical Studies	West Caldwell	New Jersey
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Quigley Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety of a three times daily application of QR-333 as compared to placebo.		12 Weeks	Yes
Secondary	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.		12 weeks	No