Muscarinic Receptor Antagonists as a Therapy for Diabetic Neuropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

May 1, 2014

Primary Completion Date

August 17, 2017

Study Completion Date

December 31, 2017

Conditions
Diabetic; Neuropathic, Polyneuropathy (Manifestation)
Interventions
DRUG

3% oxybutynin

Topical Gelnique 3%TM (3% oxybutynin) applied daily for 20 weeks in type 2 diabetic subjects with established peripheral neuropathy. Subjects will be randomized into placebo or active drug arms and instructed in how to apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 by 2 region of skin adjacent to the initial biopsy site. Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance.

DRUG

Placebo

Non-active placebo for 3% oxybutynin

Trial Locations (1)

23510f

Eastern Virgnia Medical School, Strelitz Diabetes Center, Norfolk

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Eastern Virginia Medical School

OTHER

NCT03050827 - Muscarinic Receptor Antagonists as a Therapy for Diabetic Neuropathy | Biotech Hunter | Biotech Hunter