Actively Recruiting
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-04-15
168
Participants Needed
2
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
CONDITIONS
Official Title
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide a written informed consent.
- Male or female aged 18 years or older.
- Diagnosis of diabetic peripheral neuropathic pain and diabetic peripheral neuropathy pain for at least 3 months.
- HbA1c at or below 9.0% at screening and stable antidiabetic medication for at least 30 days prior to screening.
- Pain scale (Visual Analog Scale) between 40 mm and less than 90 mm at screening.
You will not qualify if you...
- History of severe allergies.
- Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy that may interfere with pain assessment.
- Abnormal liver or kidney function.
- Corrected QT Interval (QTc) exceeding 450 ms for males or 470 ms for females.
- No response to previous treatment with pregabalin at doses of 300 mg/day or higher or gabapentin at doses of 1200 mg/day or higher for diabetic peripheral neuropathic pain.
- History of suicidal behavior or suicide attempts.
- Participation in another clinical study within 3 months prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Research Team
L
Lei Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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