This multi-center, phase 2, randomized, single-blind, three-arm, active-controlled study is comparing repeat doses, every 28 days, of standard of care (SOC) plus ST-01 against SOC plus 1% lidocaine HCL in men experiencing chronic scrotal content pain (CSCP). The main purpose of this study is to determine if repeat injections of ST-01 are safe and effective in reducing pain. After completing a screening phase participants will be randomized into one of three groups: 1) ST-01 70 mg/mL arm, 2) ST-01 140 mg/mL arm, 3) 1% Lidocaine HCL arm (Control). Participants may receive up to 4 study treatment injections given at a minimum of 28-day intervals. Participants randomized to the Control arm will be given the opportunity to cross over to an ST-01 treatment arm after 2 study treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
63
A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.
Currently approved lidocaine
Prostate Cancer Centre - Rockyview Hospital
Calgary, Alberta, Canada
Kelowna General Hospital Clinical Research Department
Kelowna, British Columbia, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Men's Health Clinic Manitoba
Winnipeg, Manitoba, Canada
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada
The Fe/Male Health Centre
Oakville, Ontario, Canada
Mount Sinai Hospital - Men's Health Institute
Toronto, Ontario, Canada
THEO Medical
Montreal, Quebec, Canada
Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.
To evaluate the change of pain score from baseline to day 56 in the active treatment cohorts (after 1 or 2 injections of ST-01) and compare to the standard of care control group. Pain score being used is the participant reported NRS scale (measured from 0-10 where 0 is no pain and 10 is maximum pain.)
Time frame: 28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.
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