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

NCT06122012 | Unknown

• 1 other identifier: HSK16149-206
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HSK16149 capsule combined with L-carnitine hydrochloride

OTHER

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

Drug: HSK16149 20mg BID

Lipoic acid combined with L-carnitine hydrochloride

OTHER

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.

Drug: HSK16149 20mg BID

Interventions

HSK16149 20mg BID DRUG

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；

Also known as: Lipoic acid tablets 2 tablets BID；L-carnitine hydrochloride tablets 2 tablets TID

HSK16149 capsule combined with L-carnitine hydrochloride; Lipoic acid combined with L-carnitine hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign written informed consent;
• Male or female over the age of 18 (including the threshold);
• Diabetic peripheral neuralgia (DPNP) diagnosis;
• The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and \< 90 mm during screening.

You may not qualify if:

• \. Peripheral neuropathy or pain unrelated to DPN that the investigator determined might confuse the DPNP assessment;
• \. 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;
• \. Severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results:
• Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) \> 1.5 × ULN;
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 (calculated according to simplified MDRD formula);
• \. Known allergic history to test drug components or other drugs or excipients with similar chemical structure;
• \. Past suicidal behavior or suicidal intention;
• \. 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;
• \. Participated in any other clinical studies within 30 days prior to screening;
• \. The researcher determines that there are other conditions that are not suitable for participation in this study.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471000, China

RECRUITING

MeSH Terms

Interventions

BID protein, human; Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Central Study Contacts

Fangqiong Li

CONTACT

+8602867258840; lifangq@haisco.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 8, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 1, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-10

Locations

CN (1)