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

Not Applicable

Recruiting

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: HSK16149 20mg BID

• Registration Number: NCT06122012
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief Summary

Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China

Detailed Description

Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-04-30
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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:

  4. Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) > 1.5 × ULN;

  5. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated according to simplified MDRD formula);

  6. Known allergic history to test drug components or other drugs or excipients with similar chemical structure;

  7. Past suicidal behavior or suicidal intention;

  8. 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;

  9. Participated in any other clinical studies within 30 days prior to screening;

  10. The researcher determines that there are other conditions that are not suitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK16149 capsule combined with L-carnitine hydrochloride	HSK16149 20mg BID	HSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Acetyl-l-carnitine hydrochloride tablets (0.25g/ tablet) were administered orally after meals, 2 tablets 3 times a day for 12 weeks
Lipoic acid combined with L-carnitine hydrochloride	HSK16149 20mg BID	HSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Lipoic acid tablets (0.3g/ tablet) were administered half an hour before breakfast, 2 tablets once a day for 11 weeks.

Primary Outcome Measures

Name	Time	Method
To compare the efficacy and safety of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablet and lipoic acid combined with acetyl-L-carnitine hydrochloride tablet in the treatment of diabetic peripheral neuralgia	week12	Using the Analysis of Covariance (ANCOVA) model, changes in ADPS relative to baseline at 12 weeks of treatment were taken as dependent variables, and baseline values of study centers, groups, and ADPS were taken as explanatory variables, and the adjusted least squares mean and standard errors of each group were listed. The difference and 95% confidence interval of the mean change of ADPS from baseline at 12 weeks in the HSK16149 capsule combined with acetyl-L-carnitine hydrochloride group compared with the lipoic acid combined with acetyl-L-carnitine hydrochloride group were calculated.

Trial Locations

Locations (1)

The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China