Status:
RECRUITING
Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Jemincare
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Detailed Description
Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06221241
Start Date
March 25 2024
End Date
April 30 2025
Last Update
April 16 2024
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034