Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy
1 other identifier
interventional
180
1 country
16
Brief Summary
The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2008
16 active sites
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
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
November 8, 2016
CompletedNovember 8, 2016
September 1, 2016
1.6 years
June 10, 2008
July 11, 2013
September 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation
Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain". The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief).
Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)
Secondary Outcomes (13)
Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation
Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)
Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation
Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation
Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation
Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation
Baseline and Week 12
- +8 more secondary outcomes
Study Arms (2)
Placebo Gel
PLACEBO COMPARATORPlacebo Gel is vehicle without clonidine
Clonidine Topical Gel (ARC-4558)
ACTIVE COMPARATORClonidine Topical Gel contains 0.1% clonidine hydrochloride
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham, School of Medicine
Birmingham, Alabama, 35294, United States
Northern California Research
Sacramento, California, 95821, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Massachuetts Medical School, Division of Diabetes- Clinical Research Office
Worcester, Massachusetts, 01655, United States
The Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Waccamaw Pain Partners/Crescent Moon Research
Murrells Inlet, South Carolina, 29576, United States
The Nerve and Muscle Center of Texas
Houston, Texas, 77030, United States
Diabetes and Glandular Disease Center
San Antonio, Texas, 78229, United States
Strelitz Diabetes Institute, Eastern Virginia Medical School
Norfolk, Virginia, 23510, United States
Swedish Pain Center
Seattle, Washington, 98104, United States
Related Publications (2)
Campbell CM, Kipnes MS, Stouch BC, Brady KL, Kelly M, Schmidt WK, Petersen KL, Rowbotham MC, Campbell JN. Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy. Pain. 2012 Sep;153(9):1815-1823. doi: 10.1016/j.pain.2012.04.014. Epub 2012 Jun 8.
PMID: 22683276RESULTSerednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3.
PMID: 35587172DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. James Campbell
- Organization
- Arcion Therapeutics, Inc.
Study Officials
- STUDY CHAIR
James N Campbell, M.D.
Arcion Therapeutics Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
November 8, 2016
Results First Posted
November 8, 2016
Record last verified: 2016-09