A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy
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?
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?
Angela Hansen
Principal Investigator
WinSanTor, Inc
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline/Day 0
Initial assessments and baseline measurements are conducted
Treatment
Participants receive either the active topical solution or placebo once daily for 12 weeks
Safety Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pirenzepine
Find a Clinic Near You
Who Is Running the Clinical Trial?
WinSanTor, Inc
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Eastern Virginia Medical School
Collaborator