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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

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692

40%

Nausea

10%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Tumescent Solution With Dilute Epinephrine

Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ST-01 70 mg/mLExperimental Treatment1 Intervention

Group II: ST-01 140 mg/mLExperimental Treatment1 Intervention

Group III: 1% Lidocaine HCLActive Control1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sustained Therapeutics Inc.Lead Sponsor

1 Previous Clinical Trials

120 Total Patients Enrolled

Graeme Boniface, PhD.Study DirectorSustained Therapeutics Inc.

Media Library

1% Lidocaine HCL (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05707208 — Phase 2

Chronic Pain Research Study Groups: 1% Lidocaine HCL, ST-01 140 mg/mL, ST-01 70 mg/mL

Chronic Pain Clinical Trial 2023: 1% Lidocaine HCL Highlights & Side Effects. Trial Name: NCT05707208 — Phase 2

1% Lidocaine HCL (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707208 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this research actively taking place?

"Correct. Clinicaltrials.gov indicates that this clinical research, initially posted on March 21st 2023, is actively seeking participants. 63 patients are needed to be recruited from 2 distinct sites."

Answered by AI

What is the current capacity for participants in this research endeavor?

"Affirmative. The clinicaltrials.gov registry states that this trial, first published on March 21st 2023, is actively accepting participants. 63 individuals are being sought for enrolment between 2 participating medical sites."

Answered by AI

Are there any potential consequences to using ST-01 70 mg/mL on patients?

"Based on the available evidence for ST-01 70 mg/mL, our Power team assigns it a score of 2. This is because Phase 2 trials only provide data that suggests its safety but not necessarily its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05707208.

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