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

Study Overview
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Brief Summary
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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 will receive up to 4 study treatment injections at 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.

Official Title
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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

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: ST-01
* Drug: 1% Lidocaine HCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ST-01 70 mg/mL<br> | Drug: ST-01<br>* A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.<br>|
| Experimental: ST-01 140 mg/mL<br> | Drug: ST-01<br>* A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.<br>|
| Active Comparator: 1% Lidocaine HCL<br> | Drug: 1% Lidocaine HCL<br>* Currently approved lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Scrotal Content Pain, Chronic testicular pain, Chronic scrotal pain, Orchialgia, spermatic cord