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

Last updated: June 27, 2024
Sponsor: Sustained Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Chronic Pain

Treatment

1% Lidocaine HCL

ST-01

Clinical Study ID

NCT05707208
ST-CP-202
  • Ages > 19
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 sidewith 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 (LidocaineHydrochloride Injection, USP, 1%, 10 mg/mL), defined as a decrease in pain score ofat least 2 within 1 hour of injection

  6. Baseline blood levels without clinically significant abnormalities including liverfunction 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 preventpregnancy over the course of the study

Exclusion

Exclusion Criteria:

  1. Negative response to test spermatic cord block, defined as absence of a decrease inpain score of at least 2 within an hour of injection

  2. Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation ofscrotal pain

  3. History of allergic reaction to lidocaine or any component of ST-01

  4. Any contraindication to local anesthesia with lidocaine (e.g., knownhypersensitivity to anesthetics of the amide type; hypokalemia, complete heartblock, 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 ofthe participant, study conduct, or interpretation of the data.

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: 1% Lidocaine HCL
Phase: 2
Study Start date:
March 21, 2023
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Prostate Cancer Centre - Rockyview Hospital

    Calgary, Alberta T2V 1P9
    Canada

    Active - Recruiting

  • Kelowna General Hospital Clinical Research Department

    Kelowna, British Columbia V1Y 1T2
    Canada

    Active - Recruiting

  • Vancouver Prostate Centre

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Men's Health Clinic Manitoba

    Winnipeg, Manitoba R3P 2S8
    Canada

    Active - Recruiting

  • Jonathan Giddens Medicine Professional Corporation

    Brampton, Ontario L6T 4S5
    Canada

    Active - Recruiting

  • The Fe/Male Health Centre

    Oakville, Ontario L6H 3P1
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H8L6
    Canada

    Site Not Available

  • Mount Sinai Hospital - Men's Health Institute

    Toronto, Ontario M5T 3L9
    Canada

    Active - Recruiting

  • THEO Medical

    Montréal, Quebec H3M 1L3
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.