Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

This study has been completed.

First Received on June 10, 2008. Last Updated on January 22, 2010 History of Changes

Sponsor:	Arcion Therapeutics Inc
Information provided by:	Arcion Therapeutics Inc
ClinicalTrials.gov Identifier:	NCT00695565

Purpose

The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.

Condition	Intervention	Phase
Painful Diabetic Neuropathy	Drug: placebo Drug: topical clonidine (ARC-4558)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Arcion Therapeutics Inc:

Primary Outcome Measures:

mean change from Baseline in NPRS score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mean change from Baseline in NPRS score at each week [ Time Frame: weekly ] [ Designated as safety issue: No ]
Percentage of subjects who experience at least 30% or at least 50% reduction in pain intensity from Baseline to each week of treatment [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	May 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1. Placebo	Drug: placebo TID x 12 weeks
Active Comparator: 2. ARC-4558	Drug: topical clonidine (ARC-4558) TID x 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

has Type 1 or Type 2 diabetes mellitus
has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening

Exclusion Criteria:

has neuropathy secondary to non-diabetic causes
has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN
has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes
is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain
is pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695565

Locations

United States, Alabama
University of Alabama at Birmingham, School of Medicine
Birmingham, Alabama, United States, 35294
United States, California
Northern California Research
Sacramento, California, United States, 95821
Neurological Research Institute
Santa Monica, California, United States, 90404
United States, Florida
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
United States, Kentucky
Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States, 40503
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
University of Massachuetts Medical School, Division of Diabetes- Clinical Research Office
Worcester, Massachusetts, United States, 01655
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Waccamaw Pain Partners/Crescent Moon Research
Murrells Inlet, South Carolina, United States, 29576
United States, Texas
Diabetes and Glandular Disease Center
San Antonio, Texas, United States, 78229
United States, Virginia
Strelitz Diabetes Institute, Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510
United States, Washington
Swedish Pain Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Arcion Therapeutics Inc

More Information

No publications provided

Responsible Party:	James N. Campbell, MD, Chief Executive Officer, Arcion Therapeutics Inc
ClinicalTrials.gov Identifier:	NCT00695565 History of Changes
Other Study ID Numbers:	CLO-027
Study First Received:	June 10, 2008
Last Updated:	January 22, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Neurologic Manifestations
Signs and Symptoms
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 24, 2012