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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 18, 2024
Sponsor:
Information provided by (Responsible Party):
Sustained Therapeutics Inc.

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 will receive up to 4 study treatment injections at 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: ST-01 Drug: 1% Lidocaine HCL Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
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
Official Title: 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
Actual Study Start Date : March 21, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: ST-01 70 mg/mL Drug: ST-01
A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.

Experimental: ST-01 140 mg/mL Drug: ST-01
A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.

Active Comparator: 1% Lidocaine HCL Drug: 1% Lidocaine HCL
Currently approved lidocaine




Primary Outcome Measures :
  1. 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.)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05707208


Contacts
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Contact: Lesley Parker (604) 875-5594 lparker@sustainedtx.com
Contact: Graeme Boniface (604) 875-5594 gboniface@prostatecentre.com

Locations
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Canada, Alberta
Prostate Cancer Centre - Rockyview Hospital Recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Ms. Christabel Yawson    403-943-8951    christabel.y@prostatecancercentre.ca   
Principal Investigator: Geoffrey Gotto, MD         
Canada, British Columbia
Vancouver Prostate Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: ST-CP-202 Study Clinical Trials Coordinator    604-875-4111 ext 67898    clinic@ubcurology.com   
Principal Investigator: Ryan Flannigan, MD         
Canada, Manitoba
Men's Health Clinic Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3P 2S8
Contact: Gayle - Clinical Trial Coordinator    204-221-4476    info@mhclinic.ca   
Principal Investigator: Premal Patel, MD         
Canada, Ontario
Jonathan Giddens Medicine Professional Corporation Recruiting
Brampton, Ontario, Canada, L6T 4S5
Contact: Ms. Walaa Elrahwan       elrahwan.walaa@gmail.com   
Principal Investigator: Jonathan Giddens, MD         
The Fe/Male Health Centre Recruiting
Oakville, Ontario, Canada, L6H 3P1
Contact: Ms. Rupinder Dhaliwal    1 905 338 3130    rdhaliwal@malehealth.com   
Principal Investigator: Richard W. Casey, MD         
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: A.Ross -Clinical Trials Coordinator       amanross@toh.ca   
Principal Investigator: Luke Witherspoon, MD         
Mount Sinai Hospital - Men's Health Institute Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: A. Marian    416-586-5964    menshealth@sinaihealth.ca   
Principal Investigator: Keith Jarvi, MD         
Canada, Quebec
THEO Medical Recruiting
Montréal, Quebec, Canada, H3M 1L3
Contact: Alain-Steve Theodat, Dr. PH, MSc.    1-438-320-7171    atheodat@theomedical.ca   
Principal Investigator: Jean-Baptiste Lattouf, MD         
Sponsors and Collaborators
Sustained Therapeutics Inc.
Investigators
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Study Director: Graeme Boniface, PhD. Sustained Therapeutics Inc.
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Responsible Party: Sustained Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05707208    
Other Study ID Numbers: ST-CP-202
First Posted: January 31, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sustained Therapeutics Inc.:
Chronic Scrotal Content Pain
Chronic testicular pain
Chronic scrotal pain
Orchialgia
spermatic cord
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action