To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia

A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia

Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.

Study Overview

• Status: Completed
• Conditions: Herpetic Neuralgia
• Intervention / Treatment: Drug: HSK16149 20mg BID; Drug: HSK16149 40mg BID; Drug: Pregabalin 150mg

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent;
• Males or females aged 18 years and older ;
• Patients must have herpetic neuralgia;
• At Screening, pain scale (VAS) of ≥ 40 mm;
• At Screening, pain scale (NRS) of ≥ 4.

Exclusion Criteria:

• Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash;
• AST/ALT > 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN;
• Serum Creatine > 176μmol/L;
• Any active infections at screening;
• History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;
• Participated in another clinical study within 30 days prior to screening;
• Pregnant or breastfeeding at screening ;
• Other conditions unlikely to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK16149 20mg BID	Drug: HSK16149 20mg BID; HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
Experimental: HSK16149 40mg BID	Drug: HSK16149 40mg BID; HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
Active Comparator: Pregabalin 150mg BID	Drug: Pregabalin 150mg; pregabalin, orally twice a day, treatment period; 150 mg (75 mg twice daily) for 1 week；300 mg (150 mg twice daily) daily for 3 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4	Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]	Baseline and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )		Baseline and week 4
Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4	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	Baseline and week 4
Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4	The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep.	Baseline and week 4

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.
• Investigators: Study Chair: Fangqiong Li, Haisco

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: HSK16149-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No