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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
Sponsor:
Information provided by (Responsible Party):
Ryan Flannigan, MD, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Lidocaine Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : August 12, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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:
  • ST-CP Lidocaine
  • ST-CP
  • Sustained-release lidocaine




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 28 days ]
    Determination of safety and tolerability of the study treatment ST-CP through the assessment of adverse events


Secondary Outcome Measures :
  1. NRS Pain Score [ Time Frame: 28 days ]
    Determination of daily maximum pain score over 14 and 28 days

  2. Validated Chronic Epididymitis Symptom Index (CESI) [ Time Frame: 28 days ]
    Determination of the pain associated quality of life

  3. Validated International Index of Erectile Function (IIEF-5) [ Time Frame: 28 days ]
    Determination of erectile function associated quality of life



Information from the National Library of Medicine

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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 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.

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): NCT04026945


Contacts
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Contact: Genevive Moreau 604-875-4111 ext 67898 gbaloloy@prostatecentre.com
Contact: Jonathan Ma 604-875-5675

Locations
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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      
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Ryan Flannigan, MD University of British Columbia
Principal Investigator: Ryan Paterson, MD University of British Columbia

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Responsible Party: Ryan Flannigan, MD, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04026945     History of Changes
Other Study ID Numbers: H19-00438
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ryan Flannigan, MD, University of British Columbia:
chronic scrotal pain
chronic testicular pain
spermatic cord
orchialgia
chronic scrotal content pain

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
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