NCT05763550

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
Last Updated

November 8, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 28, 2023

Last Update Submit

November 7, 2023

Conditions

Herpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    Baseline and week 4

  • Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4

    Baseline and week 4

Study Arms (3)

HSK16149 20mg BID

EXPERIMENTAL
Drug: HSK16149 20mg BID

HSK16149 40mg BID

EXPERIMENTAL
Drug: HSK16149 40mg BID

Pregabalin 150mg BID

ACTIVE COMPARATOR
Drug: Pregabalin 150mg

Interventions

HSK16149 20mg BIDDRUG

HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.

HSK16149 20mg BID
HSK16149 40mg BIDDRUG

HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.

HSK16149 40mg BID
Pregabalin 150mgDRUG

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

Pregabalin 150mg BID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

BID protein, humanPregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Fangqiong Li

    Haisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

February 27, 2023

Primary Completion

June 22, 2023

Study Completion

August 7, 2023

Last Updated

November 8, 2023

Record last verified: 2023-02

Locations

CN(1)