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

JMKX0623-201

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

2024-03-25

2025-03-14

2025-04-30

Recruiting

Early phase I

220

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2024-04-16