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Completed

NCT Number: NCT05763550

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

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

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Key information

Conditions

Herpetic Neuralgia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HSK16149 20mg BID

Drug

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

HSK16149 40mg BID

Drug

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

Pregabalin 150mg

Drug

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 outcomes

  1. 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

  1. 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

  2. Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4

    Time frame: Baseline and 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

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

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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