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

Herpetic Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763550
• Other study ID #: HSK16149-205
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2023
• Est. completion date: August 7, 2023

Study information

• Verified date: February 2023
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: August 7, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpetic Neuralgia
• Neuralgia

Intervention

Drug:
• HSK16149 20mg BID
HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
• HSK16149 40mg BID
HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
• 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

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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