Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HSK16149, which is being tested to see if it can help relieve pain in Chinese patients suffering from diabetic peripheral neuropathic pain (DPNP). This type of pain is often caused by diabetes and can be quite uncomfortable. The trial specifically includes patients who have not found enough relief from another medication called pregabalin, after taking it for at least four weeks. The goal is to determine if HSK16149 is more effective and safe compared to continuing with pregabalin.

To be eligible for this study, participants must be between 18 and 75 years old and have been diagnosed with DPNP for at least six months. They should also have a specific pain level, as measured by a pain scale, and must have stable blood sugar levels while taking diabetes medications. Throughout the trial, participants will receive treatment for four weeks and will be monitored for any side effects. It's important to note that certain health conditions or medications may prevent someone from joining the trial, so potential participants should discuss their situation with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent;
• • 2. Males or females aged 18-75 years of age inclusive;
• • 3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
• • 4. HbA1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;
• • 5. Have a visual analog scale (VAS) pain value ≥60 mm in the past 24 h during screening;
• • 6. DPNP patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response.
• Exclusion Criteria:
• • 1. Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
• • 2. Skin conditions in the area affected by neurupathy that could alter sensation.
• • 3. Chronic systemic diseases that may affect subjects' participation in the study.
• 4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:
• • 1. Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L;
• • 2. AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN;
• • 3. Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2;
• • 4. Creatine kinase \> 2.0 × ULN.
• • 5. History of substance abuse or alcohol abuse.
• • 6. Acute complications of diabetes in the 6 months prior to screening.
• • 7. Any active infections at screening.
• • 8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.
• • 9. Inability or unwillingness to discontinue any other prohibited concomitant medications.
• • 10. History of allergic or medically significant adverse reaction to investigational products or their excipients, duloxetine or related compounds.
• • 11. History of suicidal behavior or attempted suicide.
• • 12. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period.
• • 13. Participated in another clinical study within 30 days prior to screening.
• • 14. Other conditions of the subjects who are unlikely to comply with the protocol.
• • 15. The investigators determine that there are other conditions that are not suitable for participation in this study.