Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674008
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sichuan Haisco Pharmaceutical Group Co., Ltd.

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Propofol

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674008


Locations
Layout table for location information
China
West China Hospital, Sichuan University
Changde, China
Sponsors and Collaborators
Sichuan Haisco Pharmaceutical Group Co., Ltd.
Layout table for additonal information
Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03674008    
Other Study ID Numbers: HSK3486-301
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sichuan Haisco Pharmaceutical Group Co., Ltd.:
Sedation anesthesia gastrointestinal endoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics