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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04494815
Registration number
NCT04494815
Ethics application status
Date submitted
28/07/2020
Date registered
31/07/2020
Date last updated
5/08/2022
Titles & IDs
Public title
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
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Scientific title
A Phase 1b, Randomised, Double-blind, Placebo- and Active Controlled, Single Dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients With Peripheral Neuropathic Pain
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Secondary ID [1]
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SR419-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Neuropathic Pain
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SR419
Treatment: Drugs - active control
Treatment: Drugs - SR419 placebo
Treatment: Drugs - active control placebo
Experimental: Treatment A - Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Active comparator: Treatment B - Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Placebo comparator: Treatment C - Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
Treatment: Drugs: SR419
Each participant will receive 1 dose of 20 mg SR419 oral suspension.
Treatment: Drugs: active control
Each participant will receive 1 dose of 300 mg active control capsule.
Treatment: Drugs: SR419 placebo
Each participant will receive 2 doses of SR419 placebo oral suspension.
Treatment: Drugs: active control placebo
Each participant will receive 2 doses of active control placebo capsule.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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QST of an affected area.
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Assessment method [1]
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QST: Quantitative sensory testing
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Timepoint [1]
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Up to Day18(-2~+5) for the safety follow up since Day1
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Secondary outcome [1]
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The incidence, frequency, and severity of TEAEs.
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Assessment method [1]
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TEAE: Treatment-Emergent Adverse Events
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Timepoint [1]
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Up to Day18(-2~+5) for the safety follow up since Day1
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Secondary outcome [2]
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Spontaneous pain score
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Assessment method [2]
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Pain score will be assessed via painDETECT questionnaire with a value range of 0\~38, which includes three situations: If a subject gets a score of 0\~12, it means a neuropathic pain component is unlikely(less than 15% probability); if a score of 13\~19, it means the result is ambiguous, however, a neuropathic pain component can be present; if the score is equal to or greater than nineteen, it means a neuropathic pain is likely(more than 90% probability).
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Timepoint [2]
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Up to Day18(-2~+5) for the safety follow up since Day1
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Secondary outcome [3]
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QST of an unaffected area.
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Assessment method [3]
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Timepoint [3]
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Up to Day18(-2~+5) for the safety follow up since Day1
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Secondary outcome [4]
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Plasma concentration of SR419 after dosing.
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Assessment method [4]
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Timepoint [4]
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Up to Day11(+3)
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Eligibility
Key inclusion criteria
1. Aged =18 years at the time of informed consent.
2. Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN.
3. Average daily pain over the last week prior to Screening to be of at least moderate severity (a score of =4 on the 11-point numeric rating scale [NRS]) and be of face, limb or torso location.
4. A minimum score of 19 on the pain DETECT questionnaire.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality.
3. Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients.
4. Participants on controlled-release opioids (e.g., morphine) unless on a stable dose of Morphine Equivalent Dose (assessed by the Faculty of Pain Medicine Opioids Calculator) of up to and including 60 mg/day, at the discretion of the Investigator. Participants on instant-release opioids (e.g., codeine, oxycodone) must withhold dosing for 12 hours prior to administration of study drug.
5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
6. Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) <60 mL/min.
7. A history of major psychiatric disorder(s).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2022
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Clinical Research Facility Medical School, University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
SIMR (Australia) Biotech Pty Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain
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Trial website
https://clinicaltrials.gov/study/NCT04494815
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kai Wu
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Address
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SIMR
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04494815
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