Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
This study has been completed.
Sponsor:
Arcion Therapeutics Inc
Information provided by:
Arcion Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00695565
First received: June 10, 2008
Last updated: January 22, 2010
Last verified: January 2010
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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:
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 16, 2013