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

Phase 2

Recruiting

• Conditions: Chronic Pain
• Interventions: Drug: ST-01; Drug: 1% Lidocaine HCL

• Registration Number: NCT05707208
• Lead Sponsor: Sustained Therapeutics Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-01-31
• Study Start: 2023-03-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

1. Adult (≥ 19 years) male
2. Unilateral or bilateral scrotal pain lasting > 3 months
3. Have nociceptive scrotal pain
4. Average daily maximum scrotal pain score over 7 days ≥ 4 on the 0-10 NRS (Appendix 2). Participants with bilateral scrotal pain must be able to distinguish one side with pain score ≥ 4 and the opposite side must have a maximum scrotal pain score of ≤ 3.0 at baseline.
5. Positive response to test spermatic cord block with 1% lidocaine (Lidocaine Hydrochloride Injection, USP, 1%, 10 mg/mL), defined as a decrease in pain score of at least 2 within 1 hour of injection
6. Baseline blood levels without clinically significant abnormalities including liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], and alkaline phosphatase [ALP]) no greater than 50% above the upper limit of normal
7. If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Exclusion Criteria

1. Negative response to test spermatic cord block, defined as absence of a decrease in pain score of at least 2 within an hour of injection
2. Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation of scrotal pain
3. History of allergic reaction to lidocaine or any component of ST-01
4. Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type; hypokalemia, complete heart block, anticoagulants (aspirin permitted), antiarrhythmic medication.)
5. Active infection involving the urinary tract or scrotum
6. Inability to give consent
7. Inability to follow up according to the protocol
8. Negative response to previous spermatic cord block
9. Any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ST-01 70 mg/mL	ST-01	-
ST-01 140 mg/mL	ST-01	-
1% Lidocaine HCL	1% Lidocaine HCL	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.	28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.	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.)

Trial Locations

Locations (8)

Men's Health Clinic Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

THEO Medical; 🇨🇦 Montréal, Quebec, Canada

Prostate Cancer Centre - Rockyview Hospital; 🇨🇦 Calgary, Alberta, Canada

Kelowna General Hospital Clinical Research Department; 🇨🇦 Kelowna, British Columbia, Canada

Jonathan Giddens Medicine Professional Corporation; 🇨🇦 Brampton, Ontario, Canada

Mount Sinai Hospital - Men's Health Institute; 🇨🇦 Toronto, Ontario, Canada

Vancouver Prostate Centre; 🇨🇦 Vancouver, British Columbia, Canada

The Fe/Male Health Centre; 🇨🇦 Oakville, Ontario, Canada