Chronic PainPhase 1/2NCT04026945
Sustained Release Lidocaine for Treatment of Scrotal Pain
A Phase 1/2 study testing Lidocaine in people with Chronic Pain, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2019to 24 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Lidocaine
- Keywords
- chronic scrotal pain, chronic testicular pain, spermatic cord, orchialgia, chronic scrotal content pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called ST-CP Lidocaine, ST-CP, Sustained-release lidocaine
Sustained-release lidocaine injection
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Determination of safety and tolerability of the study treatment ST-CP through the assessment of adverse events
Measured: 28 days
Secondary outcomes (3)
NRS Pain Score
Determination of daily maximum pain score over 14 and 28 days
Measured: 28 days
Validated Chronic Epididymitis Symptom Index (CESI)
Determination of the pain associated quality of life
Measured: 28 days
Validated International Index of Erectile Function (IIEF-5)
Determination of erectile function associated quality of life
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start31 Oct 2019
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Flannigan, MD, University of British Columbia
- Investigators
- Ryan Flannigan, MD, Principal investigator, University of British ColumbiaRyan Paterson, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026945
- Sponsor's protocol ID
- H19-00438
- Status last verified
- Oct 2021
- First submitted
- 17 Jul 2019
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04026945
- Acronym / sponsor ID
- H19-00438
- Conditions
- Chronic Pain
- Keywords
- chronic scrotal pain, chronic testicular pain, spermatic cord, orchialgia, chronic scrotal content pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment (ST-CP) Group | Other | Drug: LidocaineThis 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: ST-CP Lidocaine, ST-CP, Sustained-release lidocaineSustained-release lidocaine injection | Drug | Active Treatment (ST-CP) Group |
Primary outcome
Adverse Events
Time frame: 28 days
Determination of safety and tolerability of the study treatment ST-CP through the assessment of adverse events
3 secondary outcomes
NRS Pain Score
Time frame: 28 days
Validated Chronic Epididymitis Symptom Index (CESI)
Time frame: 28 days
Validated International Index of Erectile Function (IIEF-5)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Flannigan, MD principal investigator
University of British Columbia
Ryan Paterson, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lidocaine in people with Chronic Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.