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

Sponsor

Sustained Therapeutics Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05707208

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: ST-01 Drug: 1% Lidocaine HCL	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single blind. Participant will not know what study arm they have been randomized to.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ST-01 70 mg/mL

Drug: ST-01

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

Experimental: ST-01 140 mg/mL

Drug: ST-01

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

Active Comparator: 1% Lidocaine HCL

Drug: 1% Lidocaine HCL

Currently approved lidocaine

Outcome Measures

Primary Outcome Measures

Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days. [28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.]
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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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