A Study Evaluating the Efficacy and Safety of HSK3486

NCT03709056 | Completed Phase 2 DMC

• 1 other identifier: HSK3486-203
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Sedation and Anesthesia for Adult Colonoscopy Procedures

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 (5)

• 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

  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

  during the colonoscopy procedure on day 1

Study Arms (2)

HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg

EXPERIMENTAL

Drug: HSK3486

Propofol 2.0/1.0mg/kg group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

HSK3486 DRUG

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

HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg

Propofol DRUG

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.

Propofol 2.0/1.0mg/kg group

Eligibility Criteria

• Age: 18 Years - 70 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;
• Male or female patients, ASA grade I\~III, aged ≥ 18 and≤ 70;
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
• the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤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.
• 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 before screening.
• 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) 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 (8)

West China Hospital, Sichuan University

Changde, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

The Third Xiangya Hospital of Central South University

Changsha, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

Shanghai Fengxian District Central Hospital

Shanghai, China

Location

The second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

General Hospital of Ningxia Medical University

Yinchuan, 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 17, 2018
• Study Start: December 14, 2017
• Primary Completion: February 2, 2018
• Study Completion: August 9, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

CN (8)