A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chroni… (NCT05707208) | Clinical Trial Compass
CompletedPhase 2
A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain
Canada63 participantsStarted 2023-03-21
Plain-language summary
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.
Who can participate
Age range19 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult (≥ 19 years) male
✓. Unilateral or bilateral scrotal pain lasting \> 3 months
✓. Have nociceptive scrotal pain
✓. 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
✓. 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
✓. If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study
Exclusion criteria
What they're measuring
1
Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.
Timeframe: 28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.
. 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
✕. Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation of scrotal pain
✕. History of allergic reaction to lidocaine or any component of ST-01
✕. 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.)
✕. Active infection involving the urinary tract or scrotum
✕. Inability to give consent
✕. Inability to follow up according to the protocol
✕. Negative response to previous spermatic cord block