To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
NCT ID: NCT05890053
Last Updated: 2025-09-04
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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COMPLETED
PHASE3
301 participants
INTERVENTIONAL
2022-02-17
2023-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HSK16149 40mg BID
HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
HSK16149 40mg BID
HSK16149 40mg ， orally twice a day, treatment period; 52-weeks fixed dose.
Interventions
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HSK16149 40mg BID
HSK16149 40mg ， orally twice a day, treatment period; 52-weeks fixed dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to understand and voluntarily sign informed consent.
Exclusion Criteria
2. In double-blind study, EOT visit (V10) eGFR\< 60 mL/min//1.73m2
3. Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
4. Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening \[further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)\], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded).
5. Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period.
6. The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.
18 Years
75 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 Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Emergency General Hospital
Beijing, Beijing Municipality, China
The Three Gorges Hospital Affiliated to Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
The Third Hospital of Hebei Medical University
Shijiangzhuang, Hebei, China
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
Wuhan Central Hospital
Wuhan, Hubei, China
Nanjing First People's Hospital
Nanjing, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Baotou Central Hospital
Baotou, Neimenggu, China
Jinan Central Hospital
Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
Countries
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Other Identifiers
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HSK16149-303
Identifier Type: -
Identifier Source: org_study_id
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