Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia
Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
301
HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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.
Time frame: From week 1 to week 53
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)
Time frame: From week 1 to week 53
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