Status:
COMPLETED
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
Lead Sponsor:
Shanghai SIMR Biotechnology Co., Ltd.
Conditions:
Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain
Detailed Description
This is a three-period, complete crossover, double-blind, randomised, placebo- and active-controlled study to compare the preliminary efficacy of a single dose of SR419 to placebo and active control i...
Eligibility Criteria
Inclusion
- Aged ≥18 years at the time of informed consent.
- Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN.
- 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.
- A minimum score of 19 on the pain DETECT questionnaire.
Exclusion
- Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
- Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality.
- Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients.
- 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.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) \<60 mL/min.
- A history of major psychiatric disorder(s).
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04494815
Start Date
September 18 2020
End Date
July 31 2022
Last Update
August 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Facility Medical School, University of Adelaide
Adelaide, South Australia, Australia, 5000