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

NCT05707208 | Completed Phase 2 DMC

• 1 other identifier: ST-CP-202
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Pain

Keywords

Chronic Scrotal Content Pain; Chronic testicular pain; Chronic scrotal pain; Orchialgia; spermatic cord

Outcome Measures

Primary Outcomes (1)

• 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.)

  28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.

Study Arms (3)

ST-01 70 mg/mL

EXPERIMENTAL

Drug: ST-01

ST-01 140 mg/mL

EXPERIMENTAL

Drug: ST-01

1% Lidocaine HCL

ACTIVE COMPARATOR

Drug: 1% Lidocaine HCL

Interventions

ST-01 DRUG

A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.

ST-01 140 mg/mL; ST-01 70 mg/mL

1% Lidocaine HCL DRUG

Currently approved lidocaine

1% Lidocaine HCL

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 19 years) male
• Unilateral or bilateral scrotal pain lasting \> 3 months
• Have nociceptive scrotal pain
• 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.
• 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
• 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
• If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

You may not qualify if:

• 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
• Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation of scrotal pain
• History of allergic reaction to lidocaine or any component of ST-01
• 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.)
• Active infection involving the urinary tract or scrotum
• Inability to give consent
• Inability to follow up according to the protocol
• Negative response to previous spermatic cord block
• Any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.

Sponsors & Collaborators

• Sustained Therapeutics Inc.: lead

Study Sites (8)

Prostate Cancer Centre - Rockyview Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

Kelowna General Hospital Clinical Research Department

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3P 2S8, Canada

Location

Jonathan Giddens Medicine Professional Corporation

Brampton, Ontario, L6T 4S5, Canada

Location

The Fe/Male Health Centre

Oakville, Ontario, L6H 3P1, Canada

Location

Mount Sinai Hospital - Men's Health Institute

Toronto, Ontario, M5T 3L9, Canada

Location

THEO Medical

Montreal, Quebec, H3M 1L3, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Graeme Boniface, PhD.

  Sustained Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind. Participant will not know what study arm they have been randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: March 21, 2023
• Primary Completion: December 4, 2025
• Study Completion: January 21, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)