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A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy

NCT04005287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-12-16

No results posted yet for this study

Summary

This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy.

Conditions

Interventions

DRUG

WST-057 (4% pirenzepine) Lose Dose 2mL

Topical Solution

DRUG

WST-057 (4% pirenzepine) High Dose 4mL

Topical Solution

DRUG

Placebo Low Dose

Topical Solution

DRUG

Placebo High Dose

Topical Solution

Sponsors & Collaborators

  • WinSanTor, Inc

    lead INDUSTRY

Principal Investigators

  • Angela Hansen · WinSanTor, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2021-12-15
Completion
2021-12-15
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04005287 on ClinicalTrials.gov