Actively Recruiting
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-07-08
90
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin
CONDITIONS
Official 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
- Age between 18 and 75 years old
- Diagnosed with diabetic peripheral neuropathic pain and diabetic peripheral neuropathy pain for at least 6 months
- HbA1c less than or equal to 11.0% at screening and stable anti-diabetic treatment for at least 30 days prior
- Visual Analog Scale (VAS) pain score of 60 mm or higher in the past 24 hours during screening
- Currently on continuous Pregabalin treatment for more than 4 weeks with inadequate response
You will not qualify if you...
- Peripheral neuropathy or pain not related to diabetic peripheral neuropathic pain that may affect assessment
- Skin conditions in the area affected by neuropathy that could change sensation
- Chronic systemic diseases affecting study participation
- Severe blood, liver, or kidney dysfunction, including low neutrophils, platelets, hemoglobin, elevated liver enzymes, low kidney function, or high creatine kinase
- History of substance or alcohol abuse
- Acute diabetes complications within 6 months prior to screening
- Any active infections at screening
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Inability or unwillingness to stop prohibited medications
- History of allergic or significant adverse reactions to study drugs or related compounds
- History of suicidal behavior or attempts
- Pregnant, breastfeeding, or unwilling to use reliable contraception during the study and for 28 days after
- Participation in another clinical trial within 30 days prior to screening
- Other conditions making compliance with the study unlikely
- Investigator judgment deeming participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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