To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
NCT ID: NCT05763550
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
331 participants
INTERVENTIONAL
2023-02-27
2023-08-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin
NCT06490484
Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
NCT02868801
Pregabalin Treatment and Prevention Post-herpetic Neuralgia
NCT03186443
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
NCT00612105
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
NCT01848730
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HSK16149 20mg BID
HSK16149 20mg BID
HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
HSK16149 40mg BID
HSK16149 40mg BID
HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
Pregabalin 150mg BID
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fangqiong Li
Role: STUDY_CHAIR
Haisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSK16149-205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.