Clinical Trials

What Trials are Sustained Therapeutics Conducting?

Sustained Therapeutics is conducting clinical trials for our innovative and patented sustained-release formulation of Lidocaine, called ST-01, for several different pain indications. Below is information about each ongoing clinical trial.

If you wish to participate in one of our clinical trials, kindly contact the nearest site directly from the list provided below for eligibility requirements. You can also find more detailed information about the studies from the links below each study on ClinicalTrials.gov, which is a public registry of clinical trials conducted globally.

What is a clinical trial?

A clinical trial is a research study that treats volunteer patients with an investigational drug in order to develop new treatments or medications for diseases and medical conditions. Virtually all medical advancements are thanks to the many volunteer patients that participate in clinical trials each year furthering the information about potential new drugs that could ultimately help millions of patients.

Each clinical trial is regulated in Canada by Health Canada, and outside of Canada by regulatory bodies in each country where the trial is being conducted. Clinical trials are required to be conducted in compliance with strict regulations and the data submitted to the regulatory body for review in order to ensure new drugs are safe and effective for the patients they are intended to treat.

What is a clinical trial?

Clinical Trial

ST-CP-201-Sustained Release Lidocaine for the Treatment of Postoperative Pain

The ST-CP-201 Clinical trial is being conducted in subjects that are scheduled for pelvic surgery (inguinal incision, circumcision, scrotal surgery or hemorrhoidectomy). The study is being conducted at 2 centers in Vancouver and is expected to enroll approximately 60 participants. The purpose of the study is to determine if a single injection of ST-01 is safe and effective in reducing post-operative pain and opioid use as compared to a control group who receive the current standard of care.

ST-CP-201-Sustained Release Lidocaine for the Treatment of Postoperative Pain

British Columbia

Vancouver Prostate Centre

Vancouver, British Columbia, Canada, V5Z 1M9

Contact: Clinical Trials Coordinator, 604-875-4111 ext. 67898

clinic@ubcurology.com

Principal Investigator: Ryan Flannigan, MD

Department of Surgery, St. Paul’s Hospital

Vancouver, British Columbia, Canada V6Z 1Y6

Contact: ST-CP-201 Study, Clinical Trials Coordinator

604-682-2344 ext. 66040

mobermayer@providencehealth.bc.ca

Principal Investigator:  Dr. Amandeep Ghuman

Clinical Trial

ST-CP-202 -A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain

The ST-CP-202 Clinical trial is being conducted in male patients that have been experiencing chronic scrotal pain for more than 3 months. The study is being conducted at 4 centers across Canada and is expected to enroll approximately 63 participants. The purpose of the study is to determine if repeat injections of ST-01 are safe and effective in reducing chronic scrotal pain as compared to a control group receiving standard of care lidocaine.
In this study, all control participants will be given the opportunity to crossover to an ST-01 treatment arm.

ST-CP-202 - A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain

British Columbia

Vancouver Prostate Centre

Vancouver, British Columbia, Canada, V5Z 1M9

Contact: Clinical Trials Coordinator, 604-875-4111 ext. 67898

clinic@ubcurology.com

Principal Investigator: Ryan Flannigan, MD

Manitoba

Men’s Health Clinic Manitoba

Winnipeg, Manitoba, Canada, R3P 2S8

Contact: Landon – Clinical Trial Coordinator

204-221-4476

info@mhclinic.ca

Principal Investigator: Premal Patel, MD

Ontario

Mt. Sinai Hospital – Men’s Health Institute

Toronto, Ontario, Canada, M5G 1X5

Contact: Clinical Trials Coordinator

416-586-5964

menshealth@sinaihealth.ca

Principal Investigator: Keith Jarvi, MD

The Ottawa Hospital – Civic Campus

Ottawa, Ontario, Canada, K1Y 4E9

Contact: Clinical Trials Coordinator

613-545-5104

amanross@toh.ca

Principal Investigator: Luke Witherspoon, MD