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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00695565
Other study ID # CLO-027
Secondary ID
Status Completed
Phase Phase 2
First received June 10, 2008
Last updated January 22, 2010
Start date May 2008
Est. completion date December 2009

Study information

Verified date January 2010
Source Arcion Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
placebo
TID x 12 weeks
topical clonidine (ARC-4558)
TID x 12 weeks

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Arcion Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean change from Baseline in NPRS score 12 weeks No
Secondary mean change from Baseline in NPRS score at each week weekly No
Secondary Percentage of subjects who experience at least 30% or at least 50% reduction in pain intensity from Baseline to each week of treatment weekly No
See also
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Terminated NCT01129960 - Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain Phase 3
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Completed NCT00980746 - Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy Phase 2
Completed NCT04786340 - A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy Phase 2
Completed NCT03769675 - Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation N/A
Completed NCT03755934 - Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy Phase 2