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

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: NCT03773042
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Sichuan Haisco Pharmaceutical Group Co., Ltd.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Propofol

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.




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 ]


Information from the National Library of Medicine

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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.

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): NCT03773042


Locations
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China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sponsors and Collaborators
Sichuan Haisco Pharmaceutical Group Co., Ltd.
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Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03773042    
Other Study ID Numbers: HSK3486-201
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics