RecruitingPhase 2NCT06221241
Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
Sponsor
Jemincare
Enrollment
220 participants
Start Date
Mar 25, 2024
Study Type
INTERVENTIONAL
Summary
A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Able to understand the procedures of this trial and provide written informed consent voluntarily;
- Age ≥ 18 years, male or female;
- Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
- Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
- HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.
Exclusion Criteria4
- With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
- Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
- Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
- Known treatment failure on pregabalin or gabapentin;
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Interventions
DRUGJMKX000623
tablets for oral administration.
DRUGPregabalin
capsules for oral administration.
DRUGPlacebo
matched to JMKX000623 and Pregabalin
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06221241