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

• ClinicalTrials.gov Identifier: NCT03773042
• Recruitment Status: Completed
• First Posted: December 12, 2018
• Last Update Posted: December 13, 2018
• 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:

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

Condition or disease	Intervention/treatment	Phase
Colonoscopy	Drug: HSK3486; Drug: Propofol	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IIa, Multi-center, Open-label, Non-randomized, Active-controlled, and Dose-escalation Clinical Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion for Sedation/Anesthesia in Patients Undergoing Diagnostic Colonoscopy
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: HSK3486; 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg	Drug: HSK3486; For induction and maintenance of sedation.
Active Comparator: Propofol; 1.0mg/kg, 2.0mg/kg	Drug: Propofol; For induction and maintenance of sedation.

Outcome Measures

Primary Outcome Measures :

1. Rate of successful colonoscopies. [ Time Frame: From the first dose of the study drug to removal of colonoscope on day 1 ]

Secondary Outcome Measures :

1. Insertion time [ Time Frame: From the first dose of study drug until insertion of colonoscope on day 1 ]
2. The success rate of the colonoscopy procedure [ Time Frame: From the first dose of the study drug to removal of colonoscope on day 1 ]
   The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group
3. Time to fully alert [ Time Frame: From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1 ]
4. Time to discharge [ Time Frame: From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1 ]
5. Application of study drug and alternative medication [ Time Frame: During the colonoscopy procedure on day 1 ]
   Total dosages of study drug and alternative medication
6. Mini-Mental State Examinations (MMSE) [ Time Frame: During the screening and the colonoscopy procedure 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 (those who meet all of the following are eligible)

1. 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);
2. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
3. 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;
4. 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.

Exclusion Criteria (those who meet any one of the following are ineligible):

1. Patients having contraindications to general anesthesia or previous history of anesthesia accidents;
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated;

3. Patient received any of the following drugs or therapies prior to screening:

   1. Participated in other drug clinical trials within 3 month prior to screening;
   2. In receipt of propofol and/or opioid analgesics within 1 month prior to screening;
4. 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.

5. Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:

   1. ANC ≤ 1.5 x 109/L;
   2. PLT ≤ 80 x 109/L;
   3. Hb ≤ 90 g/L (no blood transfusion within the last 14 days);
   4. AST and ALT ≥ 2.5 x ULN;
   5. TBIL ≥ 1.5 x ULN;
   6. Creatinine ≥ 1.5 x ULN.
6. History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);
7. History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);
8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Patients who are planning pregnancy within 1 month after the completion of the trial (including male patients);
9. Potential difficult airway or difficult tracheal intubation, as determined by the investigator, and/or history of intubation failure;
10. Patients determined by the investigator to be unsuitable for participating in this trial for any reason.

Contacts and Locations

Locations

China, Sichuan

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Sponsors and Collaborators

Sichuan Haisco Pharmaceutical Group Co., Ltd

More Information

• Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd
• ClinicalTrials.gov Identifier: NCT03773042
• Other Study ID Numbers: HSK3486-201
• First Posted: December 12, 2018
• Last Update Posted: December 13, 2018
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

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