Trials / Completed
CompletedNCT03709056
A Study Evaluating the Efficacy and Safety of HSK3486
A Phase IIb, Randomized, Double-blind, Propofol-controlled, Multi-center Study Evaluating the Efficacy and Safety of HSK3486 for Sedation and Anesthesia in Patients Undergoing Diagnostic Colonoscopy.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HSK3486 | HSK3486 intravenous (iv) 0.4(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old |
| DRUG | Propofol | Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old. |
Timeline
- Start date
- 2017-12-14
- Primary completion
- 2018-02-02
- Completion
- 2018-08-09
- First posted
- 2018-10-17
- Last updated
- 2018-10-18
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03709056. Inclusion in this directory is not an endorsement.