Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
372
HSK16149 20mg, orally twice a day, treatment period; 12-weeks fixed dose
HSK16149 40mg, orally twice a day, treatment period; 12-weeks fixed dose
Placebo, orally twice a day, treatment period; 12-weeks fixed dose
Dermatology Hospital of Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Compare the change from baseline in ADPS between HSK16149 and placebo at week 12
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries
Time frame: Baseline and week 12
Compare the response rate between HSK16149 and placebo at week 12 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline )
Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.
Time frame: Baseline and week 12
Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 12
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries
Time frame: From week 1 to week 12
Compare the change from baseline in Visual Analogue Scale(VAS) between HSK16149 and placebo at week 12
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
Time frame: Baseline and week 12
Compare the change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 12
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)
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Time frame: Baseline and week 12
Compare the change from baseline in Average Daily Sleep interference score(ADSIS) between HSK16149 and placebo at week 12
he sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores
Time frame: Baseline and week 12
Compare the total consumption of Acetaminophen and Paracetamol and Dihydrocodeine Tartrate between HSK16149 and placebo during the trial
Time frame: From week 1 to week 12
Compare the change from baseline in EQ-5D-5L between HSK16149 and placebo at week 12
The change from baseline in total EuroQol-5-Domain-5-Level health questionnaire
Time frame: Baseline and week 12
AE(adverse event) to evaluate the safety of HSK16149 during the trial
Number and severity of AEs
Time frame: From week 1 to week 12
Peak Plasma Concentration (Cmax) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia
Time frame: Week 4,week 8,week 10,week 12
Area under the plasma concentration versus time curve (AUC) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia
Time frame: Week 4,week 8,week 10,week 12