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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST-01 70 mg/mL | Experimental |
| |
| ST-01 140 mg/mL | Experimental |
| |
| 1% Lidocaine HCL | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-01 | Drug | A sustained release lidocaine formulation designed for the treatment of acute and chronic pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 28 days after the second injection of ST-01 or 56 days after the first injection if only one study injection is received. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Boniface, PhD. | Sustained Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prostate Cancer Centre - Rockyview Hospital | Calgary | Alberta | T2V 1P9 | Canada | ||
| Kelowna General Hospital Clinical Research Department |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Single blind. Participant will not know what study arm they have been randomized to.
| 1% Lidocaine HCL | Drug | Currently approved lidocaine |
|
| Kelowna |
| British Columbia |
| V1Y 1T2 |
| Canada |
| Vancouver Prostate Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Men's Health Clinic Manitoba | Winnipeg | Manitoba | R3P 2S8 | Canada |
| Jonathan Giddens Medicine Professional Corporation | Brampton | Ontario | L6T 4S5 | Canada |
| The Fe/Male Health Centre | Oakville | Ontario | L6H 3P1 | Canada |
| Mount Sinai Hospital - Men's Health Institute | Toronto | Ontario | M5T 3L9 | Canada |
| THEO Medical | Montreal | Quebec | H3M 1L3 | Canada |
| Aniline Compounds |
| D000588 | Amines |