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To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia

Sponsor
Haisco Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05890053
Collaborator
(none)
301
Enrollment
1
Location
1
Arm
17.6
Anticipated Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia

Condition or Disease Intervention/Treatment Phase
  • Drug: HSK16149 40mg BID
 Phase 3

Detailed Description

Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain

Study Design

Study Type:
Interventional
Actual Enrollment :
301 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 17, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Aug 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HSK16149 40mg BID

HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.

Drug: HSK16149 40mg BID
HSK16149 40mg ， orally twice a day, treatment period; 52-weeks fixed dose.
Other Names:
  • HSK16149

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia. [From week 1 to week 53]

      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

    1. Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149. [From week 1 to week 53]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/301.

    2. Able to understand and voluntarily sign informed consent.

    Exclusion Criteria:

    1. Medication compliance was < 80% in double-blind studies.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University First Hospital Beijing Beijing China 100034

    Sponsors and Collaborators

    • Haisco Pharmaceutical Group Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haisco Pharmaceutical Group Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05890053
    Other Study ID Numbers:
    • HSK16149-303
    First Posted:
    Jun 6, 2023
    Last Update Posted:
    Jun 6, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuralgia

    Study Results

    No Results Posted as of Jun 6, 2023