A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus
- Painful Diabetic Neuropathy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 2:1 ratio masking with 36 subjects assigned to active treatment, 4% WST-057 topical solution and, 18 subjects randomly assigned to a non-active matching placebo solutionMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Each subject will be randomized by an independent web-based source called IWRS. When a subject is randomized, the IWRS will assign a randomization number for each subject, corresponding to a specific treatment code. The randomization number will be automatically input into the eCRF by the system. The corresponding treatment code will only be accessible to the unblinded personnel.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This study is designed with 4 periods: screening, baseline/day 0, outpatient treatment, and safety follow-up. Site visits take place At -30 days, -7 days, Day 0, Week 3, 6, 9 and 12/end of study [EOS]. There is also a Week 14 phone call for a safety review with the subject. The purpose of this early...
This study is designed with 4 periods: screening, baseline/day 0, outpatient treatment, and safety follow-up. Site visits take place At -30 days, -7 days, Day 0, Week 3, 6, 9 and 12/end of study [EOS]. There is also a Week 14 phone call for a safety review with the subject. The purpose of this early phase 2 trial is to evaluate the overall safety and tolerability of both the active topical solution and the placebo also called the 'vehicle' formulated as a topical solution that penetrates the skin of the lower legs and tops of the feet. There are also secondary and exploratory objectives to determine if this active has efficacy properties during the 12-week treatment period as hypothesized. Even though pirenzepine is approved and used for another indication systemically, the sponsor believes the active in a topical solution to be effective in treating painful peripheral neuropathy commonly found in diabetic patients. There are both objective and subjective tests being introduced in this trial due to the unique nature of the study, and lack of defined and standardized efficacy parameters.
Tracking Information
- NCT #
- NCT04786340
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Eastern Virginia Medical School
- Investigators
- Study Director: Angela Hansen WinSanTor, Inc
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