AnalgesiaPhase 2NCT04470128

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

A Phase 2 study testing Stage I: HSK21542 0.5 μg/kg, Stage I: HSK21542 1 μg/kg and HSK21542 0.5 μg/kg in people with Analgesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Analgesia
What is being tested?: Stage I: HSK21542 0.5 μg/kg, Stage I: HSK21542 1 μg/kg and HSK21542 0.5 μg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteChina
Study dates: 19 Aug 2020to 30 Jan 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.;

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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;
Judged by the investigator to have difficult airway or judged as difficult tracheal intubation (modified Mallampati class IV) at screening;
In receipt of any one of the following medications or treatments at screening:
A time between the last use of opioid and non-opioid (such as paracetamol, aspirin [daily dose > 100 mg], indomethacin, diclofenac, parecoxib sodium, and other non-steroidal anti-inflammatory drugs) analgesics and randomization of shorter than 5 half-lives of the drug or the duration of the drug's efficacy (whichever is longer);
Longer than 10 days of continuous use of opioid analgesics for any reason within 3 months prior to screening;
Use of drugs that affect the analgesic effect within 14 days before randomization, including but not limited to: sedative-hypnotics (benzodiazepines [triazolam, diazepam, and midazolam] and non-benzodiazepines [zolpidem, zopiclone, zaleplon]), sedative-anesthetics (sevoflurane, nitrous oxide, ketamine, and etomidate), glucocorticoids (dexamethasone hydrochloride and methylprednisolone), antiepileptics (carbamazepine and sodium valproate), anxiolytics (chlordiazepoxide), antidepressants (imipramine and amitriptyline), and Chinese herbal medicines or Chinese patent medicines with analgesic and sedative effects;
A time between randomization and the last use of diuretics and compound drugs containing diuretics of shorter than 5 half-lives of the drug or the duration of the drug's efficacy (whichever is longer);
Patient whose laboratory parameters measured at screening reach the following criteria and are verified through reexamination:
WBC < 3.0 × 10^9/L;
Platelet count < 80 × 10^9/L;
Hemoglobin < 80 g/L;
Prothrombin time > 1.5 × ULN;
Activated partial thromboplastin time > 1.5 × ULN;
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 × ULN;
Total bilirubin > 1.5 × ULN;
Blood creatinine > 1.5 × ULN;
Having participated in other drug clinical trials within 3 months prior to screening (defined as having received investigational product or placebo);
Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 3 months after the trial (including male subjects);
Subject judged by the investigator to have any other factors unsuitable for involvement in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Sichuan University
Chengdu

Other trials in China

About this study

Official title: 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

Conditions: Analgesia
Being tested: Stage 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
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stage I: HSK21542 0.5 μg/kgDrug
intravenous injection
Stage I: HSK21542 1 μg/kgDrug
intravenous injection
HSK21542 0.5 μg/kgDrug
intravenous injection
HSK21542 1 μg/kgDrug
intravenous injection
HSK21542 2 μg/kgDrug
intravenous injection
PlaceboDrug
intravenous injection

Study groups in NCT04470128
Study group	Role	What they receive
Stage I: HSK21542 0.5 μg/kg	Experimental	intravenous injection Receives: Drug: Stage I: HSK21542 0.5 μg/kg
Stage I: HSK21542 1 μg/kg	Experimental	intravenous injection Receives: Drug: Stage I: HSK21542 1 μg/kg
Stage II : HSK21542 0.5 μg/kg	Experimental	intravenous injection Receives: Drug: HSK21542 0.5 μg/kg
Stage II : HSK21542 1 μg/kg	Experimental	intravenous injection Receives: Drug: HSK21542 1 μg/kg
Stage II : HSK21542 2 μg/kg	Experimental	intravenous injection Receives: Drug: HSK21542 2 μg/kg
Stage II : placebo	Placebo comparator	intravenous injection Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From administration until 24 hours after administration

Secondary outcomes (7)

Number of occurrences of BPS-NI score of > 3
The ratio of subjects with BPS-NI scores of > 3 for 0, 1, 2, 3, or more times from the insertion to the removal of colonoscope
Measured: From administration until 24 hours after administration
NRS score
NRS score of resting pain at each time point after the subject is fully awake
Measured: From administration until 24 hours after administration
Dose of propofol used
The total dose used during the induction period, maintenance period, and the entire study process
Measured: From the first dose of the study drug to removal of colonoscope on day 1
Success rate of colonoscopy diagnosis and treatment
The following two conditions must be met for successful diagnosis and treatment:
complete colonoscopy diagnosis and treatment and failure to use remedial analgesics
Measured: From the first dose of the study drug to removal of colonoscope on day 1
Time to full recovery
The time from the removal of colonoscope to when the subject opens his/her eyes and can tell his/her date of birth
Measured: On day 1
Time to discharge
The time from the removal of colonoscope to the occurrence of 3 consecutive Aldrete score of ≥ 9
Measured: On day 1
The incidence and severity of AEs
Adverse event/serious adverse event
Measured: from signing the informed consent form to the follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202030 Jan 2021

First posted14 Jul 2020
Study start19 Aug 2020
Primary completion28 Dec 2020
Study completion30 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnalgesiaStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04470128
Sponsor's protocol ID: HSK21542-202
Status last verified: Feb 2023
First submitted: 7 Jul 2020
Last updated: 21 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04470128
Acronym / sponsor ID: HSK21542-202
Conditions: Analgesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Aug 2020 (actual)
Primary completion: 28 Dec 2020 (actual)
Study completion: 30 Jan 2021 (actual)
First posted: 14 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Stage I: HSK21542 0.5 μg/kg	Experimental	Drug: Stage I: HSK21542 0.5 μg/kgintravenous injection
Stage I: HSK21542 1 μg/kg	Experimental	Drug: Stage I: HSK21542 1 μg/kgintravenous injection
Stage II : HSK21542 0.5 μg/kg	Experimental	Drug: HSK21542 0.5 μg/kgintravenous injection
Stage II : HSK21542 1 μg/kg	Experimental	Drug: HSK21542 1 μg/kgintravenous injection
Stage II : HSK21542 2 μg/kg	Experimental	Drug: HSK21542 2 μg/kgintravenous injection
Stage II : placebo	Placebo comparator	Drug: Placebointravenous injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (33 listed)

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:
Patients with the following airway management risks:
In receipt of any one of the following medications or treatments at screening:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stage I: HSK21542 0.5 μg/kgintravenous injection	Drug	Stage I: HSK21542 0.5 μg/kg
Stage I: HSK21542 1 μg/kgintravenous injection	Drug	Stage I: HSK21542 1 μg/kg
HSK21542 0.5 μg/kgintravenous injection	Drug	Stage II : HSK21542 0.5 μg/kg
HSK21542 1 μg/kgintravenous injection	Drug	Stage II : HSK21542 1 μg/kg
HSK21542 2 μg/kgintravenous injection	Drug	Stage II : HSK21542 2 μg/kg
Placebointravenous injection	Drug	Stage II : placebo

Primary outcome

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

7 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.

Related trials for Analgesia

RecruitingPhase 4
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Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
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Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stage I: HSK21542 0.5 μg/kg, Stage I: HSK21542 1 μg/kg and HSK21542 0.5 μg/kg in people with Analgesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BPS-NI score>3 did not reach the proportion (time frame: From administration until 24 hours after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.