58 Participants Needed

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy

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AH
ES
CC
Overseen ByCarolina Casellini, MD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you must be on stable diabetic and pain treatments before and during the study, and certain topical pain treatments are not allowed.

What safety data exists for the treatment known as Pirenzepine?

The provided research articles do not contain specific safety data for Pirenzepine or its use in clinical trials.12345

How does the drug pirenzepine differ from other treatments for this condition?

Pirenzepine is unique because it selectively targets M1-muscarinic receptors, which allows it to reduce stomach acid secretion at lower doses without significantly affecting other bodily functions like gastrointestinal motility or heart rate. This makes it different from traditional anticholinergic drugs, which often have broader effects and more side effects.678910

Who Is on the Research Team?

AH

Angela Hansen

Principal Investigator

WinSanTor, Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

Men must use a contraceptive that is accepted by both of us, such as a condom with a diaphragm, a condom with a cervical cap, or a condom with spermicide.
Be able to report accurately and reliably symptoms, including treatment-emergent signs and symptoms.
The individual has had diabetic neuropathy for at least 12 months that has affected their lower extremities.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline/Day 0

Initial assessments and baseline measurements are conducted

1 day
1 visit (in-person)

Treatment

Participants receive either the active topical solution or placebo once daily for 12 weeks

12 weeks
4 visits (in-person), 2 visits (phone assessment)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (phone assessment)

What Are the Treatments Tested in This Trial?

Interventions

  • Pirenzepine
How Is the Trial Designed?
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
Group II: Placebo: 4 mL of matching placebo topical solution.Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

WinSanTor, Inc

Lead Sponsor

Trials
4
Recruited
190+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Eastern Virginia Medical School

Collaborator

Trials
77
Recruited
16,500+

Published Research Related to This Trial

In a safety analysis of the CHIMES study involving 1,087 stroke patients, those treated with MLC601 experienced significantly fewer serious adverse events (SAEs) compared to those receiving a placebo, particularly for patients with multiple SAEs (6.7% vs. 29.3%).
Patients on MLC601 also had a significantly lower rate of prolonged hospitalizations, suggesting that MLC601 not only reduces SAEs but may also lessen the overall healthcare burden and associated medical costs.
Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study.Venketasubramanian, N., Moorakonda, RB., Lu, Q., et al.[2020]
MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.
The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.
MetaADEDB 2.0: a comprehensive database on adverse drug events.Yu, Z., Wu, Z., Li, W., et al.[2021]
The SMART Safety dataset is the largest collection of empirical data on adverse events in healthcare, comprising 151 systematic reviews and 629 meta-analyses, which enhances the understanding of safety outcomes in randomized controlled trials.
This dataset, which includes over 2,300 trials and 362 harm outcomes, has been rigorously validated to ensure high data quality, providing a valuable resource for addressing rare adverse events and biases in evidence synthesis.
The SMART Safety: An empirical dataset for evidence synthesis of adverse events.Fan, S., Yu, T., Yang, X., et al.[2023]

Citations

Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study. [2020]
MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]
Multi-centre, multi-database studies with common protocols: lessons learnt from the IMI PROTECT project. [2022]
The SMART Safety: An empirical dataset for evidence synthesis of adverse events. [2023]
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]
Central action of pirenzepine. [2013]
Human cardiac beta1- or beta2-adrenergic receptor stimulation and the negative chronotropic effect of low-dose pirenzepine. [2013]
Pirenzepine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in peptic ulcer disease and other allied diseases. [2018]
Automated monoclonal radioimmunoassays for pirenzepine, a selective muscarinic receptor antagonist, in plasma and urine. [2019]
Cerebro-spinal fluid concentrations of pirenzepine after therapeutic dosage. [2013]
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