Back to resultsTo Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
Primary Purpose
Herpetic Neuralgia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HSK16149 20mg BID
HSK16149 40mg BID
Pregabalin 150mg
Sponsored by
About this trial
This is an interventional treatment trial for Herpetic Neuralgia
Eligibility Criteria
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.
Sites / Locations
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HSK16149 20mg BID
HSK16149 40mg BID
Pregabalin 150mg BID
Arm Description
Outcomes
Primary Outcome Measures
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]
Secondary Outcome Measures
Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )
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
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.
Full Information
NCT ID
NCT05763550
First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05763550
Brief Title
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
July 3, 2023 (Anticipated)
Study Completion Date
July 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpetic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HSK16149 20mg BID
Arm Type
Experimental
Arm Title
HSK16149 40mg BID
Arm Type
Experimental
Arm Title
Pregabalin 150mg BID
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HSK16149 20mg BID
Intervention Description
HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
HSK16149 40mg BID
Intervention Description
HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
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
Primary Outcome Measure Information:
Title
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
Description
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
Time Frame
Baseline and week 4
Secondary Outcome Measure Information:
Title
Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )
Time Frame
Baseline and week 4
Title
Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4
Description
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
Time Frame
Baseline and week 4
Title
Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4
Description
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.
Time Frame
Baseline and week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangqiong Li
Phone
+8602867258840
Email
lifangq@haisco.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangqiong Li
Organizational Affiliation
Haisco
Official's Role
Study Chair
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Tao
Phone
13986278399
Email
tjhappy@126.com
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
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