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

NCT03674008 | Completed Phase 3 DMC

• 1 other identifier: HSK3486-301
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation or Anesthesia

Keywords

Sedation anesthesia gastrointestinal endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The success rate of the gastroscopy procedure

  from the first dose of the study drug to removal of gastroscope on day 1

• The success rate of the colonoscopy and gastroscopy procedure

  from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1

• Time to induction of sedation or anaesthesia

  from the first dose of the study drug to the first MOAA/S scores≤1 on day 1

• Time to start of procedure

  From first dose of study drug until insertion of colonoscope or gastroscope on day 1

• Time to fully alert

  from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1

Study Arms (2)

HSK3486

EXPERIMENTAL

0.4mg/kg/0.2 mg/kg

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

1.5mg/kg/0.75mg/kg

Drug: Propofol

Interventions

HSK3486 DRUG

HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance.

HSK3486

Propofol DRUG

Propofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance.

Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;
• Male or female patients, ASA grade I\~II, aged ≥ 18 and \< 65;
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
• During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;
• Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.

You may not qualify if:

• Patients were contraindicated in general anesthesia.
• Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
• 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.
• Patients with a history of drug or ethanol abuse with the past 3 months.
• Patients with respiratory management difficulties (Modified Mallampati grade IV).
• Patients in receipt of any investigational drug within 30 days before screening.
• Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours prior to baseline.
• Abnormal laboratory results consisting of any of the following:
• \) 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.
• \. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

West China Hospital, Sichuan University

Changde, China

Location

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 17, 2018
• Study Start: October 9, 2018
• Primary Completion: January 9, 2019
• Study Completion: March 10, 2019
• Last Updated: July 5, 2019

Record last verified: 2018-07

Locations

CN (1)