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

Chronic Pain Clinical Trial

Official title:

A Randomized, Controlled Phase II Study of Repeat Dose ST-01 (Lidocaine Polymer Solution) vs Lidocaine for Spermatic Cord Block in Men With Chronic Scrotal Content Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707208
• Other study ID #: ST-CP-202
• Status: Recruiting
• Phase: Phase 2
• Start date: March 21, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Sustained Therapeutics Inc.
• Contact: Lesley Parker
• Phone: (604) 875-5594
• Email: lparker[@]sustainedtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• ST-01
A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.
• 1% Lidocaine HCL
Currently approved lidocaine

Locations

Country	Name	City	State
Canada	Jonathan Giddens Medicine Professional Corporation	Brampton	Ontario
Canada	Prostate Cancer Centre - Rockyview Hospital	Calgary	Alberta
Canada	Kelowna General Hospital Clinical Research Department	Kelowna	British Columbia
Canada	THEO Medical	Montréal	Quebec
Canada	The Fe/Male Health Centre	Oakville	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Mount Sinai Hospital - Men's Health Institute	Toronto	Ontario
Canada	Vancouver Prostate Centre	Vancouver	British Columbia
Canada	Men's Health Clinic Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Sustained Therapeutics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.