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

Phase 2

Completed

• Conditions: Herpetic Neuralgia
• Interventions: Drug: HSK16149 40mg BID; Drug: Pregabalin 150mg; Drug: HSK16149 20mg BID

• Registration Number: NCT05763550
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-27
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Primary Completion: 2023-06-22
• Study Completion: 2023-08-07
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK16149 40mg BID	HSK16149 40mg BID	-
Pregabalin 150mg BID	Pregabalin 150mg	-
HSK16149 20mg BID	HSK16149 20mg BID	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4	Baseline and 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
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 DSIS between HSK16149 and pregabalin at week 4	Baseline and 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.

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China