A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients

NCT ID: NCT03773042

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-06-30

Brief Summary

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

Conditions

Colonoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HSK3486

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg

Group Type: EXPERIMENTAL

HSK3486

Intervention Type: DRUG

For induction and maintenance of sedation.

Propofol

1.0mg/kg, 2.0mg/kg

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

For induction and maintenance of sedation.

Interventions

HSK3486

For induction and maintenance of sedation.

Intervention Type: DRUG

Propofol

For induction and maintenance of sedation.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients requiring diagnostic colonoscopy with an estimated examination time ≤ 30 min; males and females, ASA grade I-II, between 18 and 65 years old (inclusive);

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

3. Respiratory rate between ≥ 10 and ≤ 24 breaths per minute; SpO2 when inhaling > 95%; SBP ≥ 90 mmHg; DBP ≥ 60 mmHg; heart rate between ≥ 50 and ≤ 100 beats per minute;

4. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.

Exclusion Criteria

1. Patients having contraindications to general anesthesia or previous history of anesthesia accidents;

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

3. Patient received any of the following drugs or therapies prior to screening:

1. Participated in other drug clinical trials within 3 month prior to screening;

2. In receipt of propofol and/or opioid analgesics within 1 month prior to screening;

4. 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.

5. Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:

1. ANC ≤ 1.5 x 109/L;

2. PLT ≤ 80 x 109/L;

3. Hb ≤ 90 g/L (no blood transfusion within the last 14 days);

4. AST and ALT ≥ 2.5 x ULN;

5. TBIL ≥ 1.5 x ULN;

6. Creatinine ≥ 1.5 x ULN.

6. History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);

7. History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);

8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Patients who are planning pregnancy within 1 month after the completion of the trial (including male patients);

9. Potential difficult airway or difficult tracheal intubation, as determined by the investigator, and/or history of intubation failure;

10. Patients determined by the investigator to be unsuitable for participating in this trial for any 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

Chengdu, Sichuan, China

Countries

China

Other Identifiers

HSK3486-201

Identifier Type: -

Identifier Source: org_study_id