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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sustained Release Lidocaine for Treatment of Scrotal Pain

NCT04026945

Chronic Pain

COMPLETED PHASE1/PHASE2

A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial

NCT06301308

Bladder Cancer

WITHDRAWN PHASE3

Pharmacokinetics of Lidocaine in Healthy Adults

NCT03310970

Healthy

COMPLETED PHASE4

Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

NCT04144192

Healthy

COMPLETED PHASE1

Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

NCT04149938

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ST-01 70 mg/mL

Group Type EXPERIMENTAL

ST-01

Intervention Type DRUG

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

ST-01 140 mg/mL

Group Type EXPERIMENTAL

ST-01

Intervention Type DRUG

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

1% Lidocaine HCL

Group Type ACTIVE_COMPARATOR

1% Lidocaine HCL

Intervention Type DRUG

Currently approved lidocaine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ST-01

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

Intervention Type DRUG

1% Lidocaine HCL

Currently approved lidocaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No