Actively Recruiting
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-07-08
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the HSK16149 capsule in Chinese adults with Diabetic Peripheral Neuropathic Pain (DPNP) who have not responded well to Pregabalin treatment. This Phase 2 study compares HSK16149 to Pregabalin over a 4-week treatment period to better understand pain relief options for this condition. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd.
CONDITIONS
Brief Title
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Males or females aged 18-75 years inclusive
- Diagnosis of diabetic peripheral neuropathic pain and diabetic peripheral neuropathy pain for 6 months or more
- HbA1c less than or equal to 11.0% at screening and stable anti-diabetic medication for at least 30 days before screening
- Visual analog scale (VAS) pain score of 60 mm or higher in the past 24 hours during screening
- Currently receiving continuous pregabalin treatment for more than 4 weeks with inadequate response
You will not qualify if you...
- Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathic pain that could confuse assessment
- Skin conditions in the affected area that may alter sensation
- Chronic systemic diseases affecting participation
- Severe blood, liver, or kidney dysfunction including neutrophils below 1.5 x 10^9/L, platelets below 90 x 10^9/L, hemoglobin below 100 g/L, AST/ALT more than 2.5 times upper limit, total bilirubin over 1.5 times upper limit, eGFR less than 60 mL/min/1.73 m^2, or creatine kinase above 2 times upper limit
- History of substance or alcohol abuse
- Acute diabetes complications within 6 months before screening
- Active infections at screening
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody
- Unable or unwilling to stop prohibited medications
- History of allergic or serious reactions to study drugs or related compounds
- History of suicidal behavior or attempts
- Pregnant, breastfeeding, or unwilling to use reliable contraception during study and 28 days after last drug dose
- Participation in another clinical study within 30 days before screening
- Other conditions likely to prevent compliance with the study protocol
- Investigator's judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive study medication orally twice a day. One group takes HSK16149 20mg for a fixed period of 4 weeks. Another group takes Pregabalin with a 1-week titration followed by 3 weeks of fixed dosing.
Multiple visits during the 4-week treatment period
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
F
Fangqiong Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here