Sedation or AnesthesiaPhase 3NCT03674008
A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia
A Phase 3 study testing HSK3486 and Propofol in people with Sedation or Anesthesia, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy. The study will enroll approximately 280 adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sedation or Anesthesia
- What is being tested?
- HSK3486 and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2018to 10 Mar 2019
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;
- Male or female patients, ASA grade I~II, aged ≥ 18 and < 65;
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
- During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;
- Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.
Who cannot join
- Patients were contraindicated in general anesthesia.
- Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
- 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.
- Patients with a history of drug or ethanol abuse with the past 3 months.
- Patients with respiratory management difficulties (Modified Mallampati grade IV).
- Patients in receipt of any investigational drug within 30 days before screening.
Show all 10Show fewer
- Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours prior to baseline.
- Abnormal laboratory results consisting of any of the following:
- 1) neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5）total bilirubin≥ 1.5×ULN； 6） serum creatinine≥ 1.2×ULN. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients.
- 10. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy
This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.
The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.
- Conditions
- Sedation or Anesthesia
- Being tested
- HSK3486, Propofol
- Keywords
- Sedation anesthesia gastrointestinal endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance.
PropofolDrug
Propofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.4mg/kg/0.2 mg/kg Receives: Drug: HSK3486 |
| Propofol | Active comparator | 1.5mg/kg/0.75mg/kg Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of colonoscopy procedure
Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period.
Measured: from the first dose of the study drug to removal of colonoscope on day 1
Secondary outcomes (7)
The success rate of the gastroscopy procedure
Measured: from the first dose of the study drug to removal of gastroscope on day 1
The success rate of the colonoscopy and gastroscopy procedure
Measured: from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1
Time to induction of sedation or anaesthesia
Measured: from the first dose of the study drug to the first MOAA/S scores≤1 on day 1
Time to start of procedure
Measured: From first dose of study drug until insertion of colonoscope or gastroscope on day 1
Time to fully alert
Measured: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Time to discharge
Measured: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Measured: from time to fully alert, until time to discharge on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start9 Oct 2018
- Primary completion9 Jan 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation or AnesthesiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674008
- Sponsor's protocol ID
- HSK3486-301
- Status last verified
- Jul 2018
- First submitted
- 11 Sep 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy
- ClinicalTrials.gov ID
- NCT03674008
- Acronym / sponsor ID
- HSK3486-301
- Conditions
- Sedation or Anesthesia
- Keywords
- Sedation anesthesia gastrointestinal endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 17 Sep 2018 (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.
This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.
The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.4mg/kg/0.2 mg/kg |
| Propofol | Active comparator | Drug: Propofol1.5mg/kg/0.75mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;
- Male or female patients, ASA grade I~II, aged ≥ 18 and < 65;
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
- During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;
- Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.
Key exclusion criteria (10 listed)
- Patients were contraindicated in general anesthesia.
- Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
- 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.
- Patients with a history of drug or ethanol abuse with the past 3 months.
- Patients with respiratory management difficulties (Modified Mallampati grade IV).
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 |
|---|---|---|
| HSK3486HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance. | Drug | HSK3486 |
| PropofolPropofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance. | Drug | Propofol |
Primary outcome
Success of colonoscopy procedure
Time frame: from the first dose of the study drug to removal of colonoscope on day 1
Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period.
7 secondary outcomes
The success rate of the gastroscopy procedure
Time frame: from the first dose of the study drug to removal of gastroscope on day 1
The success rate of the colonoscopy and gastroscopy procedure
Time frame: from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1
Time to induction of sedation or anaesthesia
Time frame: from the first dose of the study drug to the first MOAA/S scores≤1 on day 1
Time to start of procedure
Time frame: From first dose of study drug until insertion of colonoscope or gastroscope on day 1
Time to fully alert
Time frame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Time to discharge
Time frame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Time frame: from time to fully alert, until time to discharge on day 1
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 5 Jul 2019.
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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 3 study testing HSK3486 and Propofol in people with Sedation or Anesthesia, run by Sichuan 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 5 inclusion and 10 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 5 Jul 2019. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Success of colonoscopy procedure (time frame: from the first dose of the study drug to removal of colonoscope on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.