Sustained Release Lidocaine for Treatment of Scrotal Pain
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|ClinicalTrials.gov Identifier: NCT04026945|
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Lidocaine||Phase 1 Phase 2|
The purpose of this study is to find out if a new polymeric, water-free formulation of lidocaine is safe and can provide effective, long-lasting pain relief in chronic scrotal pain (CSCP) patients. This new formulation ST-CP is injected into the spermatic cord of patients in a very comparable way that the currently available lidocaine solution (Lidocaine HCl 1% USP) is administered. The only difference is that the polymer solution stays in the area of injection longer by forming a soft implant.
The investigators therefore hypothesize that the polymer formulation of lidocaine will release the drug over an extended period of time and will not dissolve away like the currently used lidocaine solution (Lidocaine HCl 1%, USP). This will lead to long-lasting pain relief for CSCP patients.
The investigators' primary objective is to determine if the single injection of our polymeric lidocaine formulation is well tolerated by patients with CSCP. Secondary objectives are to determine the duration and extent of pain relief, the impact of ST-CP on pain-related quality of life and the systemic exposure to lidocaine.
The clinical study is conducted at the Vancouver Prostate Centre. Potential participants will undergo a screening period to determine basal pain levels over 7 days and test their ability to respond to a spermatic cord block with a standard lidocaine injection (Lidocaine HCl 1%, USP). Up to 15 men will receive our ST-CP study formulation and will be monitored over the the following 4 weeks. Follow-up procedures will include blood draws, daily pain evaluations and standard questionnaires on scrotal pain and erectile function. Up to 3 dose levels are planned but dose escalation will only occur once the previous cohort (3 patients) has completed the follow up and safety assessment.
Summary descriptive statistics (including mean and standard deviation, median, range, proportion) will be provided for important parameters and outcome measures. These include subject demographics, subject disposition, subject compliance, pharmakokinetic laboratory test outcomes, overall adverse events, adverse events related to lidocaine and adverse events related to study procedure. Pain scores and questionnaires will be summarized by score and pre- and post- treatment levels will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose-Escalating Phase I Study of a Single Injection of Lidocaine Paste (ST-CP) for Spermatic Cord Block in Men With Chronic Scrotal Content Pain|
|Estimated Study Start Date :||August 12, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
Active Treatment (ST-CP) Group
This study uses a dose-escalating approach in the active treatment arm. There is no comparator product. All qualifying patients receive the active treatment ST-CP as an injection in the region around the spermatic cord. The following dosing cohorts will be used:
I: 1 x 2 mL of 140 mg/mL ST-CP (= 280 mg lidocaine) II: 1 x 3 mL of 140 mg/mL ST-CP (= 420 mg lidocaine) III: 1 x 4 mL of 140 mg/mL ST-CP (= 560 mg lidocaine)
Sustained-release lidocaine injection
- Adverse Events [ Time Frame: 28 days ]Determination of safety and tolerability of the study treatment ST-CP through the assessment of adverse events
- NRS Pain Score [ Time Frame: 28 days ]Determination of daily maximum pain score over 14 and 28 days
- Validated Chronic Epididymitis Symptom Index (CESI) [ Time Frame: 28 days ]Determination of the pain associated quality of life
- Validated International Index of Erectile Function (IIEF-5) [ Time Frame: 28 days ]Determination of erectile function associated quality of life
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): NCT04026945
|Contact: Genevive Moreau||604-875-4111 ext firstname.lastname@example.org|
|Contact: Jonathan Ma||604-875-5675|
|Canada, British Columbia|
|Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Genevive Moreau 604-875-4111 ext 67898|
|Principal Investigator:||Ryan Flannigan, MD||University of British Columbia|
|Principal Investigator:||Ryan Paterson, MD||University of British Columbia|