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Local Anesthetic

Sustained Release Lidocaine for Chronic Pain

Phase 2

Recruiting

Research Sponsored by Sustained Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Negative response to previous spermatic cord block

Active infection involving the urinary tract or scrotum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days after the second injection of st-01 or 56 days after the first injection if only one study injection is received.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if injections of ST-01 can reduce pain in men w/ chronic scrotal content pain. Participants randomized to 3 groups, up to 4 injections at 28-day intervals. Control arm can crossover to ST-01 after 2 injections.

Who is the study for?

This trial is for adult men (19+) with chronic scrotal pain lasting over 3 months, who've had a positive response to a lidocaine test block. They must have normal-ish blood liver tests and use birth control if sexually active. Men with allergies to lidocaine, other major pain sources, or certain medical conditions can't join.

What is being tested?

The study compares the safety and effectiveness of ST-01 in two different doses against standard care plus 1% Lidocaine HCL in reducing chronic scrotal pain. Participants will be randomly assigned to one of three groups and receive up to four injections every 28 days.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as swelling or discomfort, possible allergic reactions for those sensitive to ingredients in ST-01 or Lidocaine, and general side effects associated with local anesthetics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience significant scrotal pain, averaging a score of 4 or more.

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I experienced less pain after a lidocaine test on my spermatic cord.

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I have had pain in one or both testicles for more than 3 months.

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I am a man aged 19 or older.

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I experience pain in my scrotum that is sharp or aching.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I did not respond to a previous nerve block in my groin.

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I currently have an infection in my urinary tract or scrotum.

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I have pain from another condition that scores 4 or more on a pain scale.

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I am unable to understand and give consent for treatment.

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I cannot follow the study's required schedule or procedures.

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My pain did not decrease by 2 points after a numbing shot in the groin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days after the second injection of st-01 or 56 days after the first injection if only one study injection is received.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days after the second injection of st-01 or 56 days after the first injection if only one study injection is received.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after the second injection of st-01 or 56 days after the first injection if only one study injection is received. for reporting.