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

Arcion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Placebo Gel; Drug: Clonidine Topical Gel (ARC-4558)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00695565

CLO-027

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Placebo Gel

Placebo Comparator group

Description:

Placebo Gel is vehicle without clonidine

Treatment:

Drug: Placebo Gel

Clonidine Topical Gel (ARC-4558)

Active Comparator group

Description:

Clonidine Topical Gel contains 0.1% clonidine hydrochloride

Treatment:

Drug: Clonidine Topical Gel (ARC-4558)