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Trial record 1 of 1 for:    ST-CP-202
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A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain

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ClinicalTrials.gov Identifier: NCT05707208
Recruitment Status : Recruiting
First Posted : January 31, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Sustained Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE January 20, 2023
First Posted Date  ICMJE January 31, 2023
Last Update Posted Date April 26, 2024
Actual Study Start Date  ICMJE March 21, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2023)		 Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days. [ Time Frame: 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.)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Single blind. Participant will not know what study arm they have been randomized to.
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: ST-01
    A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.
  • Drug: 1% Lidocaine HCL
    Currently approved lidocaine
Study Arms  ICMJE
  • Experimental: ST-01 70 mg/mL
    Intervention: Drug: ST-01
  • Experimental: ST-01 140 mg/mL
    Intervention: Drug: ST-01
  • Active Comparator: 1% Lidocaine HCL
    Intervention: Drug: 1% Lidocaine HCL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2023)		 63
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult (≥ 19 years) male
  2. Unilateral or bilateral scrotal pain lasting > 3 months
  3. Have nociceptive scrotal pain
  4. 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.
  5. 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
  6. 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
  7. If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Exclusion Criteria:

  1. 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
  2. Other pain generator site with NRS pain score ≥ 4 that interferes with evaluation of scrotal pain
  3. History of allergic reaction to lidocaine or any component of ST-01
  4. 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.)
  5. Active infection involving the urinary tract or scrotum
  6. Inability to give consent
  7. Inability to follow up according to the protocol
  8. Negative response to previous spermatic cord block
  9. Any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lesley Parker (604) 875-5594 lparker@sustainedtx.com
Contact: Graeme Boniface (604) 875-5594 gboniface@prostatecentre.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05707208
Other Study ID Numbers  ICMJE ST-CP-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sustained Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sustained Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Graeme Boniface, PhD. Sustained Therapeutics Inc.
PRS Account Sustained Therapeutics Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP