A Study Evaluating the Efficacy and Safety of HSK3486

NCT ID: NCT03709056

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2018-08-09

Brief Summary

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.

Conditions

Sedation and Anesthesia for Adult Colonoscopy Procedures

Study Design

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

Study Groups

HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg

Group Type: EXPERIMENTAL

HSK3486

Intervention Type: DRUG

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

Propofol 2.0/1.0mg/kg group

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Scheduled to undergo a diagnostic or therapeutic colonoscopy;

2. Male or female patients, ASA grade I~III, aged ≥ 18 and≤ 70;

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

4. the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤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.

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 before screening.

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) 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: 70 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

The Second Xiangya Hospital of Central South University

Changsha, , China

The Third Xiangya Hospital of Central South University

Changsha, , China

Sichuan Provincial People's Hospital

Chengdu, , China

Shanghai Fengxian District Central Hospital

Shanghai, , China

The second Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

General Hospital of Ningxia Medical University

Yinchuan, , China

Countries

China

Other Identifiers

HSK3486-203

Identifier Type: -

Identifier Source: org_study_id