Sustained Release Lidocaine for Chronic Pain

Recruiting at 9 trial locations

Overseen By Graeme Boniface

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Sustained Therapeutics Inc.

Must not be taking: Antiarrhythmics, Anticoagulants

Disqualifiers: Allergy to lidocaine, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ST-01 (a form of lidocaine) to determine its safety and effectiveness in reducing chronic scrotal content pain (CSCP) in men. Participants will be divided into three groups to receive either two different doses of ST-01 or a standard treatment with 1% lidocaine. The goal is to identify which treatment best eases pain. Men who have experienced scrotal pain for more than three months and have found some relief from lidocaine injections might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in pain management.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiarrhythmic medication or have a contraindication to lidocaine, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ST-01, a pain-relief injection, is safe and generally well-tolerated. In earlier studies, patients used ST-01 without major safety issues, and it was easy to administer, meaning most people handled the treatment well.

For 1% lidocaine HCL, evidence supports its safety. Lidocaine often relieves pain, and studies confirm its effectiveness and safety for long-term use. People using lidocaine usually experience few side effects, making it a reliable choice for pain management.

Previous research has proven both ST-01 and lidocaine safe, so participating in a study with these treatments may involve manageable risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic pain because they offer a new sustained-release approach. Unlike standard treatments like opioids or traditional lidocaine patches, ST-01—available in 70 mg/mL and 140 mg/mL doses—delivers lidocaine in a way that maintains therapeutic levels over time, potentially reducing the need for frequent applications. This could mean more consistent pain relief with fewer side effects and a lower risk of dependency. Additionally, the innovative delivery system sets ST-01 apart from typical pain management strategies by targeting pain more directly and efficiently.

What evidence suggests that this trial's treatments could be effective for chronic scrotal content pain?

Research shows that treatments using lidocaine can help manage long-term pain. Studies have found that lidocaine reduces pain by blocking nerve signals in the body. In this trial, participants will receive either 1% Lidocaine HCL or ST-01, a new lidocaine formula. Early results for ST-01 suggest it effectively targets pain areas and may relieve conditions like chronic scrotal content pain (CSCP). ST-01 is designed to release lidocaine slowly, potentially providing longer-lasting relief. While more data is needed, these early signs are promising for those seeking new ways to manage pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Graeme Boniface, PhD.

Principal Investigator

Sustained Therapeutics Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 study treatment injections of ST-01 or 1% Lidocaine HCL at a minimum of 28-day intervals

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 1% Lidocaine HCL
• ST-01

Trial Overview 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.

How Is the Trial Designed?

Group I: ST-01 70 mg/mL Experimental Treatment 1 Intervention

Group II: ST-01 140 mg/mL Experimental Treatment 1 Intervention

Group III: 1% Lidocaine HCL Active Control 1 Intervention

1% Lidocaine HCL is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Approved in European Union as Lignocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Approved in Canada as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Who Is Running the Clinical Trial?

Sustained Therapeutics Inc.

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

The modified thermoresponsive poloxamer-based formulation for lidocaine showed sustained release for up to 72 hours, with a significant reduction in burst release when polyvinyl pyrrolidone was added, indicating improved control over drug delivery.

Lidocaine released into ex vivo human intra-articular fluid occurred 1.4 times faster than in phosphate-buffered saline, suggesting that the formulation can effectively target pain relief in the knee joint after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and ex vivo characterisation of an in situ gelling formulation for sustained lidocaine release with potential use following knee arthroplasty. Sharma, M., Chandramouli, K., Curley, L., et al.[2021]

In a study involving 40 participants, a topical gel mixture of lidocaine and prilocaine (2.5% each) was found to be significantly more effective than 20% benzocaine in reducing pain from needle insertion in the maxillary vestibule.

The majority of subjects (87.5% to 100% over time) reported that the lidocaine/prilocaine side was less painful, with statistically significant results indicating better pain relief (p < 0.05) compared to benzocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pain from needle stick in the oral mucosa by topical anesthetics: a comparative study between lidocaine/prilocaine and benzocaine. Abu Al-Melh, M., Andersson, L., Behbehani, E.[2022]

In a study of 101 patients, Emla (lignocaine/prilocaine) cream significantly reduced pain during sharp debridement of chronic leg ulcers, with median pain scores of 18 mm for Emla compared to 53.5 mm for placebo (p < 0.0001).

The safety profile of Emla was favorable, with only mild and transient local reactions reported at similar rates in both Emla and placebo groups, indicating it is a safe option for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. Rosenthal, D., Murphy, F., Gottschalk, R., et al.[2018]

A patient developed an allergic contact dermatitis from prilocaine, confirmed through patch testing, which also showed cross-reactivity with articaine but not with other amide anesthetics like lidocaine or mepivacaine.

The study highlights the importance of testing multiple amide anesthetics in cases of suspected delayed-type allergies, as there are no established rules for cross-reactivity among them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact allergy and cross-reactions caused by prilocaine. Suhonen, R., Kanerva, L.[2013]

The study found that a methylcellulose-based formulation of lidocaine and prilocaine (P-L) significantly enhances the absorption of these anesthetics through the skin compared to the carbopol-based Eutectic Mixture of Local Anesthesia (EMLA), with higher concentrations detected in the dermis.

Using a microdialysis system, the researchers demonstrated that the P-L formulation resulted in greater area under the concentration-time curve (AUC) and maximal concentrations (Cmax) for both lidocaine and prilocaine, indicating improved efficacy in local anesthesia delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous penetration kinetics of lidocaine and prilocaine in two local anesthetic formulations assessed by in vivo microdialysis in pigs. Wei, H., Chen, Y., Xu, L., et al.[2019]

The lidocaine/tetracaine medicated plaster effectively reduces pain during minor dermatological and vascular access procedures, showing significantly lower patient-reported pain scores compared to placebo and lidocaine/prilocaine cream in clinical trials.

Systemic absorption of the active ingredients from the plaster is minimal after a 1-hour application, indicating a localized effect with a good safety profile, as the treatment was well tolerated with only minor, self-resolving adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine/tetracaine medicated plaster: in minor dermatological and needle puncture procedures. Croxtall, JD.[2021]

A 24-hour application of EMLA cream (5-10 g) to painful leg ulcers in 10 patients resulted in safe plasma concentrations of lignocaine and prilocaine, well below toxic levels, indicating a low risk of systemic absorption.

The study found that peak plasma levels of lignocaine increased with higher doses, and the cream was well tolerated, suggesting that EMLA could be a safe option for managing chronic ulcer pain, warranting further investigation into its analgesic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma concentrations of lignocaine and prilocaine after a 24-h application of analgesic cream (EMLA) to leg ulcers. Stymne, B., Lillieborg, S.[2019]

In a study involving 30 patients undergoing axillary brachial plexus anaesthesia, both lidocaine and prilocaine provided a similar mean onset time of surgical analgesia at 10 minutes, indicating their effectiveness as local anesthetics.

Pharmacokinetically, while both lidocaine and prilocaine were eliminated rapidly, prilocaine had a higher total body clearance compared to lidocaine, suggesting it may be metabolized more efficiently, making both drugs suitable options for regional anaesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects and disposition kinetics of lidocaine and (+/-)prilocaine in patients undergoing axillary brachial plexus block during day case surgery. Simon, MA., Vree, TB., Gielen, MJ., et al.[2021]

Articaine, introduced in 1976 and widely used since 1986, has become the most popular local anesthetic in dentistry, surpassing lignocaine due to its effective pain control and rapid action.

Compared to older anesthetics, articaine offers enhanced safety and efficacy, making it a valuable addition to the local anesthetic options available to dental practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New anesthetics]. Malamed, SF.[2013]

Alkalinizing prilocaine with 8.4% NaHCO3 did not change the onset or termination times for sensory block but significantly prolonged the duration of motor block compared to standard prilocaine.

Patients receiving the alkalinized prilocaine reported higher satisfaction and experienced less intense tourniquet pain, suggesting it may be a more effective option for hand-wrist surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of low volume prilocaine and alkalinized prilocaine for the regional intravenous anesthesia technique in hand and wrist surgery. Kapusuz, O., Argun, G., Arikan, M., et al.[2021]

In a study of 66 patients undergoing hemodialysis, EMLA cream (lidocaine/prilocaine) provided significantly better pain relief during arteriovenous fistula puncture compared to lidocaine tape, with a notable improvement of 10.1 mm on a 100-mm visual analog scale.

Both treatments were safe, with no drug-related adverse events reported, and there was no significant difference in quality of life between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the pain-reducing effects of EMLA cream and of lidocaine tape during arteriovenous fistula puncture in patients undergoing hemodialysis: A multi-center, open-label, randomized crossover trial. Fujimoto, K., Adachi, H., Yamazaki, K., et al.[2020]

The study found that both the lidocaine-tetracaine (LT cream) and lidocaine-prilocaine (LP cream) formulations are chemically stable for over 3 months and have similar release rates for lidocaine, indicating their potential effectiveness as local anesthetics.

In terms of skin penetration and anesthetic action, LT cream showed comparable results to LP cream in guinea pigs, suggesting that LT cream could be a viable, cost-effective alternative for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anesthetic cream prepared from lidocaine-tetracaine eutectic mixture. Ohzeki, K., Kitahara, M., Suzuki, N., et al.[2019]

A topical gel containing 2.5% lidocaine and 3.5% prilocaine significantly reduced discomfort during 35% trichloroacetic acid (TCA) peels, with 8 out of 10 patients reporting at least a 40% decrease in pain compared to previous peels without anesthesia.

While effective in pain reduction, the gel may increase the depth of the peel, suggesting it should only be used with TCA concentrations below 30% to avoid potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a topical lidocaine/prilocaine anesthetic gel in 35% trichloroacetic acid peels. Rubin, MG.[2019]

Citations

1. ztlido.com ztlido.com/quality-of-life/

When functional improvement with gabapentinoids isn't ... After 8 weeks of combination therapy with ZTlido, most patients rated their quality of life as much or very much improved.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10382213/

A phase 1 study of an injectable lidocaine paste for ... Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, ...

3. ztlido.com ztlido.com/

ZTlido Efficacy - ZTLido ZTlido is indicated for up to 3 patches a day (12 hours on /12 hours off delivers 24 hours of pain control).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9341344/

Open-Label Adhesion Performance Study of a Prescription ... Lidocaine topical system 1.8% demonstrated superior adhesion relative to the three lidocaine-containing OTC products over the 12-hour treatment period.

5. biospace.com biospace.com/scilex-holding-company-announces-new-data-from-deeper-skin-penetration-studies-to-support-sp-103-lidocaine-topical-system-5-4-percent-a-triple-strength-formulation-of-ztlido-in-treatment-of-musculoskeletal-pain-disorders

Scilex Holding Company Announces New Data From ... The Company believes that these results indicate that SP-103 is highly effective in delivering lidocaine into muscle tissue in areas of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7319520/

A Randomized, Open-Label, Bioequivalence Study of ... Topical lidocaine remains an effective treatment option for PHN over time, with up to 4 years of available safety and efficacy data on long-term ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04245371

Lidocaine Patch 1.8% for Moderate to Severe Pain From ... The primary objective is to determine the efficacy of Lidocaine Patch 1.8% in reducing the severity of symptoms in participants with moderate-to-severe pain ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818023001691

Effect and safety profile of topical lidocaine on post-surgical ... Topical lidocaine may lead to pain relief and is safe to use for patient with post-surgical pain, though its impact on quality of life is unclear.