To Evaluate the Efficacy and Safety of HSK16149 With L-carnitine in Diabetic Peripheral Neuralgia Patients in China

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Nov 2, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment for patients suffering from diabetic peripheral neuropathic pain, which is a type of nerve pain caused by diabetes. The researchers want to see how well HSK16149 capsules work when taken together with acetyl-L-carnitine and lipoic acid. They will compare this combination to another treatment involving acetyl-L-carnitine alone. The goal is to find out if this new treatment is safe and effective for managing pain in patients with this condition.

To participate in the study, you need to be at least 18 years old and have a confirmed diagnosis of diabetic peripheral neuropathy. It's important that your pain level is moderately high, as measured by a pain scale. However, there are some reasons you might not be eligible, such as having other types of nerve pain, serious health issues involving your liver or kidneys, or if you are pregnant or breastfeeding. If you join the study, you will receive the treatment for a specific period and will be monitored closely for any side effects or changes in your pain levels. This trial is currently looking for participants, and your involvement could help improve treatment options for others with similar pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to understand and voluntarily sign written informed consent;
• • 2. Male or female over the age of 18 (including the threshold);
• • 3. Diabetic peripheral neuralgia (DPNP) diagnosis;
• • 4. The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and \< 90 mm during screening.
• Exclusion Criteria:
• • 1. Peripheral neuropathy or pain unrelated to DPN that the investigator determined might confuse the DPNP assessment;
• • 2. History of malignant tumors (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening;
• 3. Severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results:
• • 1. Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) \> 1.5 × ULN;
• • 2. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 (calculated according to simplified MDRD formula);
• • 4. Known allergic history to test drug components or other drugs or excipients with similar chemical structure;
• • 5. Past suicidal behavior or suicidal intention;
• • 6. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
• • 7. Participated in any other clinical studies within 30 days prior to screening;
• • 8. The researcher determines that there are other conditions that are not suitable for participation in this study.