Trials / Completed
CompletedNCT03674008
A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia
A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (actual)
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-10-09
- Primary completion
- 2019-01-09
- Completion
- 2019-03-10
- First posted
- 2018-09-17
- Last updated
- 2019-07-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03674008. Inclusion in this directory is not an endorsement.