NCT05763550CompletedPhase 2
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
Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country331 target enrollmentStarted: February 27, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 331
- Locations
- 1
- Primary Endpoint
- Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
Study Overview
Brief Summary
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HSK16149 20mg BID
Experimental
Intervention: HSK16149 20mg BID (Drug)
HSK16149 40mg BID
Experimental
Intervention: HSK16149 40mg BID (Drug)
Pregabalin 150mg BID
Active Comparator
Intervention: Pregabalin 150mg (Drug)
Outcomes
Primary Outcomes
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
Time Frame: Baseline and week 4
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]
Secondary Outcomes
- Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4(Baseline and week 4)
- 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)
Investigators
Study Sites (1)
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