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

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    345
  • sponsor
    Haisco Pharmaceutical Group Co., Ltd.
Updated on 10 December 2021
herpes
rash

Summary

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo

Details
Condition Postherpetic neuralgia, Postherpetic Neuralgia, post-herpetic neuralgia
Treatment Placebo BID, HSK16149 20mg BID, HSK16149 40mg BID
Clinical Study IdentifierNCT05140863
SponsorHaisco Pharmaceutical Group Co., Ltd.
Last Modified on10 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent
Males or females aged 18-75 years of age inclusive
Outpatient, Patients can not stay in the hospital overnight
Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash
At Screening, pain scale (VAS) of 40 mm

Exclusion Criteria

Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN
Skin conditions in the area affected by neurupathy that could alter sensation
Chronic systemic diseases that may affect subjects' participation in the study
Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils < 1.5 109/L, or platelet < 90 109/L, or hemoglobin < 100 g/L, or 2)AST/ALT > 2.5 upper limit of normal (ULN), or TBIL > 1.5 ULN, or 3)Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m2, or 4)Creatine kinase > 2.0 ULN
Uncontrolled diabetes(HbA1c11.0% at screening)
History of substance abuse or alcohol abuse
Any active infections at screening
HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive
Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3)
Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia
Failure to response to previous treatment with pregabalin at doses 300 mg/d or gabapentin at doses 1200 mg/d for treatment of PHN
History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds
History of suicidal behavior or attempted suicide
Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period
Mechanical operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators
Participated in another clinical study within 30 days prior to screening
Other conditions unlikely to participate in this trial
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