Back to resultsTo Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
Primary Purpose
Peripheral Neuropathic Pain
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HSK16149 40mg BID
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathic Pain
Eligibility Criteria
Inclusion Criteria: Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301. Able to understand and voluntarily sign informed consent. Exclusion Criteria: Medication compliance was < 80% in double-blind studies. In double-blind study, EOT visit (V10) eGFR< 60 mL/min//1.73m2 Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study. 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). 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. 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.
Sites / Locations
- Peking University First Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HSK16149 40mg BID
Arm Description
HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
Outcomes
Primary Outcome Measures
To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.
Safety assessment variables included AE, ECG, laboratory test values, height and weight, physical examination, and vital signs. Safety data will be summarized by aggregate in SS and all subjects will be listed. Overall description of all AE occurred in subjects by total, and summary of cases, cases and percentage. Clinical judgments of laboratory indicators before and after drug administration (according to the range of normal values or the investigator's judgment of clinical significance) were summarized in the form of crosstabs, and the number and percentage of cases were calculated.
Secondary Outcome Measures
Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149.
Based on FAS, descriptive statistical analysis and mapping analysis were performed on the mean values of VAS, PRI and PPI scores and the mean changes from baseline of each visiting point, to compare whether there were statistical differences before and after treatment. Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:
Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe) Part 2 - a visual analog scale (VAS), in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)
Full Information
NCT ID
NCT05890053
First Posted
February 26, 2023
Last Updated
May 24, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05890053
Brief Title
To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
Official Title
A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia
Detailed Description
Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSK16149 40mg BID
Arm Type
Experimental
Arm Description
HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
HSK16149 40mg BID
Other Intervention Name(s)
HSK16149
Intervention Description
HSK16149 40mg ， orally twice a day, treatment period; 52-weeks fixed dose.
Primary Outcome Measure Information:
Title
To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.
Description
Safety assessment variables included AE, ECG, laboratory test values, height and weight, physical examination, and vital signs. Safety data will be summarized by aggregate in SS and all subjects will be listed. Overall description of all AE occurred in subjects by total, and summary of cases, cases and percentage. Clinical judgments of laboratory indicators before and after drug administration (according to the range of normal values or the investigator's judgment of clinical significance) were summarized in the form of crosstabs, and the number and percentage of cases were calculated.
Time Frame
From week 1 to week 53
Secondary Outcome Measure Information:
Title
Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149.
Description
Based on FAS, descriptive statistical analysis and mapping analysis were performed on the mean values of VAS, PRI and PPI scores and the mean changes from baseline of each visiting point, to compare whether there were statistical differences before and after treatment. Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:
Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe) Part 2 - a visual analog scale (VAS), in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)
Time Frame
From week 1 to week 53
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.
Able to understand and voluntarily sign informed consent.
Exclusion Criteria:
Medication compliance was < 80% in double-blind studies.
In double-blind study, EOT visit (V10) eGFR< 60 mL/min//1.73m2
Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
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).
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.
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.
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
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