A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Colonoscopy

NCT04470128 | Completed Phase 2

• 1 other identifier: HSK21542-202
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• BPS-NI score>3 did not reach the proportion

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

  From administration until 24 hours after administration

Secondary Outcomes (7)

• 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

Study Arms (6)

Stage I: HSK21542 0.5 μg/kg

EXPERIMENTAL

intravenous injection

Drug: Stage I: HSK21542 0.5 μg/kg

Stage I: HSK21542 1 μg/kg

EXPERIMENTAL

intravenous injection

Drug: Stage I: HSK21542 1 μg/kg

Stage II : HSK21542 0.5 μg/kg

EXPERIMENTAL

intravenous injection

Drug: HSK21542 0.5 μg/kg

Stage II : HSK21542 1 μg/kg

EXPERIMENTAL

intravenous injection

Drug: HSK21542 1 μg/kg

Stage II : HSK21542 2 μg/kg

EXPERIMENTAL

intravenous injection

Drug: HSK21542 2 μg/kg

Stage II : placebo

PLACEBO COMPARATOR

intravenous injection

Drug: Placebo

Interventions

Stage I: HSK21542 0.5 μg/kg DRUG

intravenous injection

Stage I: HSK21542 0.5 μg/kg

Stage I: HSK21542 1 μg/kg DRUG

intravenous injection

Stage I: HSK21542 1 μg/kg

HSK21542 0.5 μg/kg DRUG

intravenous injection

Stage II : HSK21542 0.5 μg/kg

HSK21542 1 μg/kg DRUG

intravenous injection

Stage II : HSK21542 1 μg/kg

HSK21542 2 μg/kg DRUG

intravenous injection

Stage II : HSK21542 2 μg/kg

Placebo DRUG

intravenous injection

Stage II : placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with the following airway management risks:
• Asthma history, and stridor;
• Sleep apnea syndrome;
• History or family history of malignant hyperthermia;
• History of failed tracheal intubation;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Stage I is open-label,Stage II is double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: August 19, 2020
• Primary Completion: December 28, 2020
• Study Completion: January 30, 2021
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)