Sustained Release Lidocaine for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
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 sustained release lidocaine generally safe for humans?
Lidocaine, used in various forms like Emla cream, is generally safe for humans, but rare cases of allergic reactions such as contact dermatitis (skin rash) have been reported. Studies have shown that lidocaine is effective in reducing pain during procedures like debridement of leg ulcers, indicating its safety in controlled medical use.12345
How is the drug 1% Lidocaine HCL, ST-01 unique for treating chronic pain?
The drug 1% Lidocaine HCL, ST-01 offers sustained release of lidocaine, which may provide longer-lasting pain relief compared to other formulations that release the drug more quickly. This sustained release mechanism is particularly beneficial for managing chronic pain, as it can maintain therapeutic levels of the drug over an extended period, potentially reducing the frequency of application.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 4 study treatment injections of ST-01 or 1% Lidocaine HCL at a minimum of 28-day intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 1% Lidocaine HCL
- ST-01
1% Lidocaine HCL is already approved in United States, European Union, Canada for the following indications:
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Who Is Running the Clinical Trial?
Sustained Therapeutics Inc.
Lead Sponsor