To Evaluate the Efficacy and Safety of HSK16149 With L-carnitine in Diabetic Peripheral Neuralgia Patients in China
NCT ID: NCT06122012
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
136 participants
INTERVENTIONAL
2023-05-01
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HSK16149 capsule combined with L-carnitine hydrochloride
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
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；
Lipoic acid combined with L-carnitine hydrochloride
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.
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；
Interventions
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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；
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSK16149-206
Identifier Type: -
Identifier Source: org_study_id
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