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Anticholinergic
Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution for Diabetes
Phase 2
Waitlist Available
Research Sponsored by WinSanTor, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial tests a medicated cream for people with Type II Diabetes who have painful feet and lower legs. The cream contains pirenzepine and is applied to the skin to help reduce pain by acting on nerve pathways.
Eligible Conditions
- Diabetes
- Diabetic Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment Emergent Adverse Events as assessed by ECG (measuring p wave, QRS complex, QT interval)
Incidence of Treatment Emergent Adverse Events as assessed by dermal assessment (Draize score 0.0-4.0) score of skin erythema, edema pruritus and dryness score) of the dosing area
Incidence of Treatment Emergent Adverse Events as assessed by hematology and clinical pathology blood tests
+1 moreSecondary study objectives
Neuropathy Total Symptom Score-6 (NTSS-6)
Norfolk Quality of Life- Diabetic Peripheral Neuropathy (Norfolk-QOL-DN)
Utah Early Neuropathy Score (UENS)
+2 moreOther study objectives
Intraepidermal Nerve Fiber Density (IENFD) of the dosing area
Norfolk Quality of Life for Diabetic Peripheral Neuropathy -Physical Large Fiber Function Subset Score
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: WST-057 active: 4 mL of WST-057 (4%; 146 mg of pirenzepine free base monohydrate) topical solutionExperimental Treatment1 Intervention
The WST-057 is the active topical solution and contains pirenzepine free base monohydrate. It is dispensed with a pump to deliver (with 4 pumps) 4 mL to the calves (mid-calf sock line), ankles and the tops of both feet. Both solutions (active and placebo) are applied once-a-day for 12 weeks.
Group II: Placebo: 4 mL of matching placebo topical solution.Placebo Group2 Interventions
The placebo solution contains the same ingredients as the active solution with the exception of the active WST-057. It is dispensed with a pump to deliver 4 mL to the calves (mid-calf sock line), ankles and the tops of both feet. Both solutions (active and placebo) are applied once-a-day for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution
2020
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
134 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,439 Previous Clinical Trials
4,324,766 Total Patients Enrolled
109 Trials studying Diabetes
138,677 Patients Enrolled for Diabetes
Eastern Virginia Medical SchoolOTHER
73 Previous Clinical Trials
15,647 Total Patients Enrolled
1 Trials studying Diabetes
156 Patients Enrolled for Diabetes
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