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

• ClinicalTrials.gov Identifier: NCT03674008
• Recruitment Status: Completed
• First Posted: September 17, 2018
• Last Update Posted: July 5, 2019
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd
• Information provided by (Responsible Party): Haisco Pharmaceutical Group Co., Ltd. ( Sichuan Haisco Pharmaceutical Group Co., Ltd )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedation or Anesthesia	Drug: HSK3486; Drug: Propofol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy
• Actual Study Start Date: October 9, 2018
• Actual Primary Completion Date: January 9, 2019
• Actual Study Completion Date: March 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: HSK3486; 0.4mg/kg/0.2 mg/kg	Drug: HSK3486; HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance.
Active Comparator: Propofol; 1.5mg/kg/0.75mg/kg	Drug: Propofol; Propofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance.

Outcome Measures

Primary Outcome Measures :

1. Success of colonoscopy procedure [ Time Frame: from the first dose of the study drug to removal of colonoscope on day 1 ]
   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.

Secondary Outcome Measures :

1. The success rate of the gastroscopy procedure [ Time Frame: from the first dose of the study drug to removal of gastroscope on day 1 ]
2. The success rate of the colonoscopy and gastroscopy procedure [ Time Frame: from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1 ]
3. Time to induction of sedation or anaesthesia [ Time Frame: from the first dose of the study drug to the first MOAA/S scores≤1 on day 1 ]
4. Time to start of procedure [ Time Frame: From first dose of study drug until insertion of colonoscope or gastroscope on day 1 ]
5. Time to fully alert [ Time Frame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1 ]
6. Time to discharge [ Time Frame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1 ]
7. Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians [ Time Frame: from time to fully alert, until time to discharge on day 1 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

China

West China Hospital, Sichuan University

Changde, China

Sponsors and Collaborators

Sichuan Haisco Pharmaceutical Group Co., Ltd

More Information

• Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd
• ClinicalTrials.gov Identifier: NCT03674008
• Other Study ID Numbers: HSK3486-301
• First Posted: September 17, 2018
• Last Update Posted: July 5, 2019
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haisco Pharmaceutical Group Co., Ltd. ( Sichuan Haisco Pharmaceutical Group Co., Ltd ):

Sedation anesthesia gastrointestinal endoscopy

Additional relevant MeSH terms:

Propofol; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics