A Randomized, Controlled Phase II Study of Repeat Dose ST-01 (Lidocaine Polymer Solution) vs Lidocaine for Spermatic Cord Block in Men With Chronic Scrotal Content Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single blind. Participant will not know what study arm they have been randomized to.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.
研究组 & 干预措施
1% Lidocaine HCL
干预措施: 1% Lidocaine HCL (Drug)
ST-01 70 mg/mL
干预措施: ST-01 (Drug)
ST-01 140 mg/mL
干预措施: ST-01 (Drug)
结局指标
主要结局
Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.
时间窗: 28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.
To evaluate the change of pain score from baseline to day 56 in the active treatment cohorts (after 1 or 2 injections of ST-01) and compare to the standard of care control group. Pain score being used is the participant reported NRS scale (measured from 0-10 where 0 is no pain and 10 is maximum pain.)
次要结局
未报告次要终点