A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week, Phase 3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Postherpetic Neuralgia

Haisco Pharmaceutical Group Co., Ltd.2 sites in 1 country372 target enrollmentNovember 1, 2021

ConditionsPostherpetic Neuralgia

InterventionsHSK16149 20mg BID HSK16149 40mg BID Placebo BID

DrugsHSK16149 20mg BID HSK16149 40mg BID Placebo BID

Overview

Phase: Phase 3
Intervention: HSK16149 20mg BID
Conditions: Postherpetic Neuralgia
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 372
Locations: 2
Primary Endpoint: Compare the change from baseline in ADPS between HSK16149 and placebo at week 12
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

January 5, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent;
•Males or females aged 18-75 years of age inclusive;
•Outpatient, Patients can not stay in the hospital overnight;
•Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;
•At Screening, pain scale (VAS) of ≥40 mm;

Exclusion Criteria

•Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;
•Skin conditions in the area affected by neurupathy that could alter sensation;
•Chronic systemic diseases that may affect subjects' participation in the study;
•Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils \< 1.5 × 109/L, or platelet \< 90 × 109/L, or hemoglobin \< 100 g/L, or 2)AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or 3)Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m2, or 4)Creatine kinase \> 2.0 × ULN.
•Uncontrolled diabetes(HbA1c≥11.0% at screening) ;
•History of substance abuse or alcohol abuse;
•Any active infections at screening;
•HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;
•Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);
•Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;

Arms & Interventions

HSK16149 20mg BID

HSK16149 20mg, orally twice a day for 12 weeks

Intervention: HSK16149 20mg BID

HSK16149 40mg BID

HSK16149 40mg, orally twice a day for 12 weeks

Intervention: HSK16149 40mg BID

Placebo BID

placebo, orally twice a day for 12 weeks

Intervention: Placebo BID

Outcomes

Primary Outcomes

Compare the change from baseline in ADPS between HSK16149 and placebo at week 12

Time Frame: Baseline and 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

Secondary Outcomes

Compare the change from baseline in Visual Analogue Scale（VAS） between HSK16149 and placebo at week 12(Baseline and week 12)
Compare the change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 12(Baseline and week 12)
Compare the change from baseline in Average Daily Sleep interference score（ADSIS） between HSK16149 and placebo at week 12(Baseline and week 12)
Area under the plasma concentration versus time curve (AUC) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia(Week 4,week 8,week 10,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 )(Baseline and week 12)
Compare the total consumption of Acetaminophen and Paracetamol and Dihydrocodeine Tartrate between HSK16149 and placebo during the trial(From week 1 to week 12)
Compare the change from baseline in EQ-5D-5L between HSK16149 and placebo at week 12(Baseline and week 12)
Peak Plasma Concentration (Cmax) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia(Week 4,week 8,week 10,week 12)
Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 12(From week 1 to week 12)
AE（adverse event） to evaluate the safety of HSK16149 during the trial(From week 1 to week 12)