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.

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

Study Overview

• Status: Completed
• Conditions: Sedation and Anesthesia for Adult Colonoscopy Procedures
• Intervention / Treatment: Drug: HSK3486; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Changde, China
    • West China Hospital, Sichuan University
  • Changsha, China
    • The Second Xiangya Hospital of Central South University
  • Changsha, China
    • The Third Xiangya Hospital of Central South University
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Shanghai, China
    • Shanghai Fengxian District Central Hospital
  • Wenzhou, China
    • The Second Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China
    • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Yinchuan, China
    • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg	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
ACTIVE_COMPARATOR: Propofol 2.0/1.0mg/kg group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of colonoscopy procedure	Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period.	from the first dose of the study drug to removal of colonoscope on day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to start of procedure		From first dose of study drug until insertion of colonoscope on day 1
The success rate of the colonoscopy procedure	The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group	from the first dose of the study drug to removal of colonoscope on day 1
Time to fully alert		from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Time to discharge		from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
Application of study drug and alternative medication	total dosages of study drug and alternative medication	during the colonoscopy procedure on day 1

Collaborators and Investigators

• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2017
• Primary Completion (ACTUAL): February 2, 2018
• Study Completion (ACTUAL): August 9, 2018

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (ACTUAL): October 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: HSK3486-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No