Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Able to understand the procedures of this trial and provide written informed consent voluntarily; 2. Age ≥ 18 years, male or female; 3. Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks; 4. Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9; 5. HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks. Exclusion Criteria: 1. With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain; 2. Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions; 3. Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial; 4. Known treatment failure on pregabalin or gabapentin;