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

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

A Study to Evaluate the Efficacy and Safety of HSK16149 Capsule Combined With L-carnitine Hydrochloride Tablets and Lipoic Acid Combined With L-carnitine Hydrochloride Tablets in Diabetic Peripheral Neuralgia Patients in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122012
• Other study ID #: HSK16149-206
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: Fangqiong Li
• Phone: +8602867258840
• Email: lifangq[@]haisco.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: May 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• HSK16149 20mg BID
HSK16149 20mg BID with L-carnitine hydrochloride tablets 2 tablets TID ;Lipoic acid tablets 2 tablets BID with L-carnitine hydrochloride tablets 2 tablets TID;

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	week12