免费获得国外相关药品，最快 1 个工作日回馈药物信息
Sustained Release Lidocaine for Treatment of Scrotal Pain
| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 31, 2019 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | March 2021 |
| Arm | Intervention/treatment |
|---|---|
|
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) |
Drug: Lidocaine
Sustained-release lidocaine injection
Other Names:
|
- 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
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult ( ≥ 19 years) male
- Unilateral scrotal pain lasting >3 months
- Average daily maximum scrotal pain score over 7 days ≥ 5 on the 0-10 NRS (see study protocol attached in 9.1.)
- Positive response to test spermatic cord block with 1% Lidocaine (Lidocaine HCl 1%, USP), defined as a temporary decrease of at least two points on the NRS (see study protocol attached in 9.1.) within an hour of injection
Exclusion Criteria:
- Negative response to test spermatic cord block, defined as absence of a temporary decrease of at least two points on the NRS (see study protocol attached in 9.1.) within an hour of injection
- Other pain generator site with NRS ≥ 5
- History of allergic reaction to lidocaine or any other component of ST-CP Lidocaine
- Known hypersensitivity to anesthetics of the amide-type.
- Complete heart block.
- Use of anticoagulants (Aspirin permitted)
- 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.
| Contact: Genevive Moreau | 604-875-4111 ext 67898 | gbaloloy@prostatecentre.com | |
| 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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 17, 2019 | ||||||||
| First Posted Date ICMJE | July 19, 2019 | ||||||||
| Last Update Posted Date | December 17, 2019 | ||||||||
| Actual Study Start Date ICMJE | October 31, 2019 | ||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Adverse Events [ Time Frame: 28 days ] Determination of safety and tolerability of the study treatment ST-CP through the assessment of adverse events
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sustained Release Lidocaine for Treatment of Scrotal Pain | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing chronic scrotal pain (CSCP). The new formulation ST-CP is a lidocaine sustained-release formulation and is expected to provide pain relief over 4 weeks. Currently, the drug lidocaine is not available as an injectable slow-release formulation and chronic scrotal pain patients are often left untreated. | ||||||||
| Detailed Description |
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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Chronic Pain | ||||||||
| Intervention ICMJE | Drug: Lidocaine
Sustained-release lidocaine injection
Other Names:
|
||||||||
| Study Arms ICMJE | 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) Intervention: Drug: Lidocaine
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 2021 | ||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04026945 | ||||||||
| Other Study ID Numbers ICMJE | H19-00438 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Ryan Flannigan, MD, University of British Columbia | ||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | University of British Columbia | ||||||||
| Verification Date | August 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
