Sustained Release Lidocaine for Treatment of Scrotal Pain

NCT04026945 | Completed Phase 1 DMC

• 1 other identifier: H19-00438
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic scrotal pain; chronic testicular pain; spermatic cord; orchialgia; chronic scrotal content pain

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Determination of safety and tolerability of the study treatment ST-CP through the assessment of adverse events

  28 days

Secondary Outcomes (3)

• NRS Pain Score

  28 days

• Validated Chronic Epididymitis Symptom Index (CESI)

  28 days

• Validated International Index of Erectile Function (IIEF-5)

  28 days

Study Arms (1)

Active Treatment (ST-CP) Group

OTHER

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

Interventions

Lidocaine DRUG

Sustained-release lidocaine injection

Also known as: ST-CP Lidocaine, ST-CP, Sustained-release lidocaine

Active Treatment (ST-CP) Group

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ryan Flannigan, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Ryan Paterson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: October 31, 2019
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

CA (1)