Clinical trial NCT05707208: A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Chronic Scrotal Content Pain
Chronic testicular pain
Chronic scrotal pain
Orchialgia
spermatic cord
Lead sponsor: Sustained Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-31
Enrollment: 63
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.
timeFrame: 28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Prostate Cancer Centre - Rockyview Hospital
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna General Hospital Clinical Research Department
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Men's Health Clinic Manitoba
state: Manitoba
city: Brampton
country: Canada
facility: Jonathan Giddens Medicine Professional Corporation
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital - Men's Health Institute
state: Ontario
city: Montréal
country: Canada
facility: THEO Medical
state: Quebec
Study officials:
affiliation: Sustained Therapeutics Inc.
name: Graeme Boniface, PhD.
role: STUDY_DIRECTOR
References: