Clinical trial NCT00695565: Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Lead sponsor: Arcion Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation
timeFrame: Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)
Secondary outcomes:
measure: Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation
timeFrame: Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)
measure: Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation
timeFrame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
measure: Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation
timeFrame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
measure: Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation
timeFrame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
measure: Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score
timeFrame: Baseline and Week 12
measure: Patient Global Impression of Change (PGIC) at Week 12
timeFrame: Week 12
measure: Clinician Global Impression of Change (CGIC) at Week 12
timeFrame: Week 12
measure: Change in Blood Pressure From Baseline to Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, School of Medicine
state: Alabama
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Lexington
country: United States
facility: Pain Treatment Center of the Bluegrass
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Worcester
country: United States
facility: University of Massachuetts Medical School, Division of Diabetes- Clinical Research Office
state: Massachusetts
city: Omaha
country: United States
facility: The Creighton Diabetes Center
state: Nebraska
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Murrells Inlet
country: United States
facility: Waccamaw Pain Partners/Crescent Moon Research
state: South Carolina
city: Houston
country: United States
facility: The Nerve and Muscle Center of Texas
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Center
state: Texas
city: Norfolk
country: United States
facility: Strelitz Diabetes Institute, Eastern Virginia Medical School
state: Virginia
city: Seattle
country: United States
facility: Swedish Pain Center
state: Washington
Study officials:
affiliation: Arcion Therapeutics Inc
name: James N Campbell, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: Serednicki 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.