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

NCT03773042 | Completed Phase 2 DMC

• 1 other identifier: HSK3486-201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of successful colonoscopies.

  From the first dose of the study drug to removal of colonoscope on day 1

Secondary Outcomes (6)

• Insertion time

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

• The success rate of the colonoscopy procedure

  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 MOAA/S scores of 9 on day 1

• Application of study drug and alternative medication

  During the colonoscopy procedure on day 1

Study Arms (2)

HSK3486

EXPERIMENTAL

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

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

1.0mg/kg, 2.0mg/kg

Drug: Propofol

Interventions

HSK3486 DRUG

For induction and maintenance of sedation.

HSK3486

Propofol DRUG

For induction and maintenance of sedation.

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:

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

You may not qualify if:

• Patients having contraindications to general anesthesia or previous history of anesthesia accidents;
• Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated;
• Patient received any of the following drugs or therapies prior to screening:
• Participated in other drug clinical trials within 3 month prior to screening;
• In receipt of propofol and/or opioid analgesics within 1 month prior to screening;
• 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.
• Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:
• ANC ≤ 1.5 x 109/L;
• PLT ≤ 80 x 109/L;
• Hb ≤ 90 g/L (no blood transfusion within the last 14 days);
• AST and ALT ≥ 2.5 x ULN;
• TBIL ≥ 1.5 x ULN;
• Creatinine ≥ 1.5 x ULN.
• History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);
• History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 12, 2018
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 13, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)