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drugset / Trial / NCT03674008

A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia

NCT03674008 ↗

Phase 3 Completed 280 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy. The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.

Timeline

Start
2018-10-09
Primary completion
2019-01-09
Completion
2019-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.2 mg/kg Intravenous
Comparator Propofol Small molecule 0.75 mg/kg Intravenous

Indications

No indication recorded.