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

NCT ID: NCT03674008

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-09
• Study Completion Date: 2019-03-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HSK3486

0.4mg/kg/0.2 mg/kg

Group Type: EXPERIMENTAL

HSK3486

Intervention Type: DRUG

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

Propofol

1.5mg/kg/0.75mg/kg

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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

Interventions

HSK3486

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

Intervention Type: DRUG

Propofol

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;

2. Male or female patients, ASA grade I~II, aged ≥ 18 and < 65;

3. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;

4. During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;

5. Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.

Exclusion Criteria

1. Patients were contraindicated in general anesthesia.

2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.

3. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.

4. Patients with a history of drug or ethanol abuse with the past 3 months.

5. Patients with respiratory management difficulties (Modified Mallampati grade IV).

6. Patients in receipt of any investigational drug within 30 days before screening.

7. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours prior to baseline.

8. Abnormal laboratory results consisting of any of the following:

1) neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5）total bilirubin≥ 1.5×ULN； 6） serum creatinine≥ 1.2×ULN. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients.

10. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital, Sichuan University

Changde, , China

Countries

China

Other Identifiers

HSK3486-301

Identifier Type: -

Identifier Source: org_study_id