NCT00568035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 8, 2009

Status Verified

January 1, 2009

Enrollment Period

1.9 years

First QC Date

December 3, 2007

Last Update Submit

January 7, 2009

Conditions

Diabetic Neuropathy

Keywords

diabeticperipheralneuropathy

Outcome Measures

Primary Outcomes (1)

  • Determine the safety of a three times daily application of QR-333 as compared to placebo.

    12 Weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

QR-333

ACTIVE COMPARATOR
Drug: QR-333

Placebo

PLACEBO COMPARATOR
Drug: QR-333

Interventions

QR-333DRUG

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

PlaceboQR-333

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • uncontrolled pain that has persisted for \> 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Seale Harris Clinic / Alliance Clinical Research

Birmingham, Alabama, 35216, United States

Location

Pacific Sleep Medicine Services, Inc

Fountain Valley, California, 92708, United States

Location

Advanced Medical Research, LLC

Lakewood, California, 90712, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Baptist Clinical Research

Pensacola, Florida, 35201, United States

Location

Stedman Clinical Trails

Tampa, Florida, 33613, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

A&A Pain Institute

St Louis, Missouri, 63141, United States

Location

Rwjms/Umdnj

New Brunswick, New Jersey, 08903, United States

Location

Land Clinical Studies

West Caldwell, New Jersey, 07006, United States

Location

Kaleida Health, Diabetes Center of WNY

Buffalo, New York, 14209, United States

Location

ECU Diabetes Research Center, Brody School of Medicine

Greenville, North Carolina, 27834, United States

Location

Hartwell Research Group / Anderson Family Care

Anderson, South Carolina, 29621, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

dgd Research

San Antonio, Texas, 78229, United States

Location

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research Center, Inc

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Philip Raskin, MD

    University of Texas, Southwestern Medical Center at Dallas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 8, 2009

Record last verified: 2009-01

Locations

US(19)