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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Lei Xing, PM
xinglei@jemincare.com
010-66119025
Backup
Xiaohui Guo, MD
010-66119025
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 220
Treatments
Experimental: JMKX000623
JMKX000623 for 12 weeks
Active_comparator: Pregabalin
Pregabalin for 12 weeks
Placebo_comparator: Placebo
placebo for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Jemincare