Sedation and Anesthesia for Adult Colonoscopy ProceduresPhase 2NCT03709056

A Study Evaluating the Efficacy and Safety of HSK3486

A Phase 2 study testing HSK3486 and Propofol in people with Sedation and Anesthesia for Adult Colonoscopy Procedures, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 8 sites 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

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sedation and Anesthesia for Adult Colonoscopy Procedures
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: 94 participants
Where: 8 sitesChina
Study dates: 14 Dec 2017to 9 Aug 2018
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled to undergo a diagnostic or therapeutic colonoscopy;
Male or female patients, ASA grade I~III, aged ≥ 18 and≤ 70;
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤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.
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 before screening.
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) 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

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

West China Hospital, Sichuan University
Changde
The Second Xiangya Hospital of Central South University
Changsha
The Third Xiangya Hospital of Central South University
Changsha
Sichuan Provincial People's Hospital
Chengdu
Shanghai Fengxian District Central Hospital
Shanghai
The second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
General Hospital of Ningxia Medical University
Yinchuan

Other trials in China

About this study

Official title: A Phase IIb, Randomized, Double-blind, Propofol-controlled, Multi-center Study Evaluating the Efficacy and Safety of HSK3486 for Sedation and Anesthesia in Patients Undergoing Diagnostic Colonoscopy.

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.

Conditions: Sedation and Anesthesia for Adult Colonoscopy Procedures
Being tested: HSK3486, Propofol

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(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old
PropofolDrug
Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old.

Study groups in NCT03709056
Study group	Role	What they receive
HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg	Experimental	Not described Receives: Drug: HSK3486
Propofol 2.0/1.0mg/kg group	Active comparator	Not described 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 (5)

Time to start of procedure
Measured: From first dose of study drug until insertion of colonoscope on day 1
The success rate of the colonoscopy procedure
The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group
Measured: from the first dose of the study drug to removal of colonoscope on day 1
Time to fully alert
Measured: from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Time to discharge
Measured: from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
Application of study drug and alternative medication
total dosages of study drug and alternative medication
Measured: during the colonoscopy procedure on day 1

Timeline

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

14 Dec 20179 Aug 2018

First posted17 Oct 2018
Study start14 Dec 2017
Primary completion2 Feb 2018
Study completion9 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedation and Anesthesia for Adult Colonoscopy ProceduresStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03709056
Sponsor's protocol ID: HSK3486-203
Status last verified: Oct 2018
First submitted: 8 Oct 2018
Last updated: 18 Oct 2018
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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Double-blind, Propofol-controlled, Multi-center Study Evaluating the Efficacy and Safety of HSK3486 for Sedation and Anesthesia in Patients Undergoing Diagnostic Colonoscopy.
ClinicalTrials.gov ID: NCT03709056
Acronym / sponsor ID: HSK3486-203
Conditions: Sedation and Anesthesia for Adult Colonoscopy Procedures
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
Study start: 14 Dec 2017 (actual)
Primary completion: 2 Feb 2018 (actual)
Study completion: 9 Aug 2018 (actual)
First posted: 17 Oct 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.

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg	Experimental	Drug: HSK3486
Propofol 2.0/1.0mg/kg group	Active comparator	Drug: Propofol

Who may qualify

Ages: 18 to 70 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;
Male or female patients, ASA grade I~III, aged ≥ 18 and≤ 70;
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤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.

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(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old	Drug	HSK3486 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg
PropofolPropofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old.	Drug	Propofol 2.0/1.0mg/kg group

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.

5 secondary outcomes

Time to start of procedure
Time frame: From first dose of study drug until insertion of colonoscope on day 1
The success rate of the colonoscopy procedure
Time frame: from the first dose of the study drug to removal of colonoscope on day 1
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
Time to discharge
Time frame: from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
Application of study drug and alternative medication
Time frame: during the colonoscopy procedure 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 18 Oct 2018.

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK3486 and Propofol in people with Sedation and Anesthesia for Adult Colonoscopy Procedures, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 8 sites 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 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?

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?

On the ClinicalTrials.gov record for NCT03709056.

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 18 Oct 2018.