Trial record 1 of 1 for:
ST-CP-202
A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05707208 |
|
Recruitment Status :
Recruiting
First Posted : January 31, 2023
Last Update Posted : April 26, 2024
|
Sponsor:
Sustained Therapeutics Inc.
Information provided by (Responsible Party):
Sustained Therapeutics Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pain | Drug: ST-01 Drug: 1% Lidocaine HCL | Phase 2 |
| 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 : | December 2024 |
| Estimated Study Completion Date : | April 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Chronic Pain
| 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 :
- 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.)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
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
| Contact: Lesley Parker | (604) 875-5594 | lparker@sustainedtx.com | |
| Contact: Graeme Boniface | (604) 875-5594 | gboniface@prostatecentre.com |
Locations
| 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 | |
| Kelowna General Hospital Clinical Research Department | Not yet recruiting |
| Kelowna, British Columbia, Canada, V1Y 1T2 | |
| Contact: ST-CP-202 Study Research Coordinator 778-214-2065 ClinicalResearchKGH@interiorhealth.ca | |
| Principal Investigator: Jennifer Locke, MD | |
| 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
| Study Director: | Graeme Boniface, PhD. | Sustained Therapeutics Inc. |
| 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 26, 2024 |
| Last Verified: | April 2024 |
| 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:
|
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 |