Chronic PainPhase 2NCT05707208
A Randomized, Controlled Study of Repeat Dose Sustained Release Lidocaine for Treatment of Chronic Scrotal Pain
A Phase 2 study testing ST-01 and 1% Lidocaine HCL in people with Chronic Pain, run by Sustained Therapeutics Inc. at 8 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ST-01 and 1% Lidocaine HCL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 8 sitesCanada
- Study dates
- 21 Mar 2023to 21 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, L6T 4S5
Prostate Cancer Centre - Rockyview Hospital
Calgary, Alberta, T2V 1P9
Kelowna General Hospital Clinical Research Department
Kelowna, British Columbia, V1Y 1T2
THEO Medical
Montreal, Quebec, H3M 1L3
The Fe/Male Health Centre
Oakville, Ontario, L6H 3P1
Mount Sinai Hospital - Men's Health Institute
Toronto, Ontario, M5T 3L9
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3P 2S8
About this study
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
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.
- Conditions
- Chronic Pain
- Being tested
- ST-01, 1% Lidocaine HCL
- Keywords
- Chronic Scrotal Content Pain, Chronic testicular pain, Chronic scrotal pain, Orchialgia, spermatic cord
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-01Drug
A sustained release lidocaine formulation designed for the treatment of acute and chronic pain.
1% Lidocaine HCLDrug
Currently approved lidocaine
| Study group | Role | What they receive |
|---|---|---|
| ST-01 70 mg/mL | Experimental | Not described Receives: Drug: ST-01 |
| ST-01 140 mg/mL | Experimental | Not described Receives: Drug: ST-01 |
| 1% Lidocaine HCL | Active comparator | Not described Receives: Drug: 1% Lidocaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 56 days.
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.)
Measured: 28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start21 Mar 2023
- Primary completion4 Dec 2025
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sustained Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graeme Boniface, PhD., Study director, Sustained Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707208
- Sponsor's protocol ID
- ST-CP-202
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05707208
- Acronym / sponsor ID
- ST-CP-202
- Conditions
- Chronic Pain
- Keywords
- Chronic Scrotal Content Pain, Chronic testicular pain, Chronic scrotal pain, Orchialgia, spermatic cord
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Sustained Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ST-01 70 mg/mL | Experimental | Drug: ST-01 |
| ST-01 140 mg/mL | Experimental | Drug: ST-01 |
| 1% Lidocaine HCL | Active comparator | Drug: 1% Lidocaine HCL |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-01A sustained release lidocaine formulation designed for the treatment of acute and chronic pain. | Drug | ST-01 140 mg/mL, ST-01 70 mg/mL |
| 1% Lidocaine HCLCurrently approved lidocaine | Drug | 1% Lidocaine HCL |
Primary outcome
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graeme Boniface, PhD. study director
Sustained Therapeutics Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ST-01 and 1% Lidocaine HCL in people with Chronic Pain, run by Sustained Therapeutics Inc. at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.