Clinical Trials/NCT04470128

NCT04470128

Completed

Phase 2

A Multi-center, Randomized, Two-stage, Phase II Clinical Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Diagnostic or Therapeutic Colonoscopy

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country180 target enrollmentAugust 19, 2020

ConditionsAnalgesia

InterventionsHSK21542 0.5 μg/kg HSK21542 1 μg/kg HSK21542 2 μg/kg Placebo

DrugsStage I: HSK21542 0.5 μg/kg Stage I: HSK21542 1 μg/kg HSK21542 0.5 μg/kg HSK21542 1 μg/kg HSK21542 2 μg/kg Placebo

Overview

Phase: Phase 2
Intervention: HSK21542 0.5 μg/kg
Conditions: Analgesia
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 180
Locations: 1
Primary Endpoint: BPS-NI score>3 did not reach the proportion
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, randomized, two-stage, phase II clinical study .The main objective is to evaluate the safety and tolerability of HSK21542 injection for analgesia in patients undergoing colonoscopy, and, combining the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics

Registry

clinicaltrials.gov

Start Date

August 19, 2020

End Date

January 30, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects undergoing diagnostic and/or therapeutic colonoscopy with an estimated operation duration of 15-45 min;
•Aged ≥ 18 and ≤ 75 years old, with no restriction on gender;
•American Society of Anesthesiologists (ASA) Class I-II;
•BMI ≥ 18 kg/m\^2 and ≤ 30 kg/m\^2;
•During screening and at baseline: respiratory rate ≥ 10 and ≤ 24 bpm; SpO2 ≥ 95% during inhalation; SBP ≥ 90 mmHg; DBP ≥ 50 mmHg; HR ≥ 50 and ≤ 100 bpm;
•Subjects with intelligence and consciousness sufficient enough for cooperating with the study;
•Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.

Exclusion Criteria

•Patients having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
•Patients with past history of allergy or contraindications to opioids, their rescue medications, and propofol;
•Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
•History of cardiovascular diseases: uncontrolled hypertension (systolic blood pressure \[SBP\] ≥ 170 mmHg and/or diastolic blood pressure \[DBP\] ≥ 105 mmHg without treatment, or SBP \> 160 mmHg and/or DBP \> 100 mmHg after antihypertensive treatment), severe arrhythmia, heart failure, Adams-Stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers);
•History of respiratory system disorders: respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory tract infection with obvious symptoms such as fever, wheezing, nasal obstruction, and cough within 1 week prior to baseline;
•History of neurological and psychiatric disorders: craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, long-term use of psychotropic drugs, and history of cognitive dysfunction; history of depression, anxiety, and epilepsy, etc.;
•History of gastrointestinal disorders: gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration;
•History of alcohol abuse within 3 months prior to screening, with abuse defined as average of \> 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
•History of drug abuse within 3 months prior to screening;
•History of blood donation or blood loss of ≥ 400 mL within 3 months prior to screening;

Arms & Interventions

Stage II : HSK21542 0.5 μg/kg

intravenous injection

Intervention: HSK21542 0.5 μg/kg

Stage II : HSK21542 1 μg/kg

intravenous injection

Intervention: HSK21542 1 μg/kg

Stage II : HSK21542 2 μg/kg

intravenous injection

Intervention: HSK21542 2 μg/kg

Stage II : placebo

intravenous injection

Intervention: Placebo

Outcomes

Primary Outcomes

BPS-NI score>3 did not reach the proportion

Time Frame: From administration until 24 hours after administration

the proportion of subjects with BPS-NI score\>3 did not appear from the beginning of insertion of colonoscopy to the removal of colonoscopy

Secondary Outcomes

Number of occurrences of BPS-NI score of > 3(From administration until 24 hours after administration)
NRS score(From administration until 24 hours after administration)
Dose of propofol used(From the first dose of the study drug to removal of colonoscope on day 1)
Success rate of colonoscopy diagnosis and treatment(From the first dose of the study drug to removal of colonoscope on day 1)
Time to full recovery(On day 1)
Time to discharge(On day 1)
The incidence and severity of AEs(from signing the informed consent form to the follow-up period)