Testing HSK16149 for pain relief in diabetic patients not helped by Pregabalin

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

This study is testing a new capsule called HSK16149 to see if it can help Chinese patients with diabetic nerve pain who didn't get enough relief from Pregabalin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06490484 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of HSK16149 capsules in Chinese patients suffering from diabetic peripheral neuropathic pain (DPNP) who have not adequately responded to Pregabalin. Participants will receive either HSK16149 or continue with Pregabalin for a duration of four weeks. The study aims to assess pain relief and safety outcomes through a visual analog scale (VAS) and other relevant measures. The trial is designed to provide insights into a potential new treatment option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18-75 with a diagnosis of diabetic peripheral neuropathic pain who have been on Pregabalin for at least four weeks without sufficient relief.

Not a fit: Patients with neuropathic pain unrelated to diabetes or those with severe systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer significant pain relief for patients with diabetic peripheral neuropathic pain who do not respond to existing therapies.

How similar studies have performed: Other studies have explored treatments for diabetic peripheral neuropathic pain, but the specific approach of HSK16149 is novel and has not been widely tested.

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.

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Fangqiong Li

Conditions Diabetic Peripheral Neuropathic Pain