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

NCT03674008 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-07-05

No results posted yet for this study

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.

Conditions

  • Sedation or Anesthesia

Interventions

DRUG

HSK3486

HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance.

DRUG

Propofol

Propofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance.

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674008 on ClinicalTrials.gov