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ColonoscopyPhase 2NCT03773042

A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients

A Phase 2 study testing HSK3486 and Propofol in people with Colonoscopy, run by Sichuan 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

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 65 years
Conditions the study is for
Colonoscopy
What is being tested?
HSK3486 and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
Dec 2016to Jun 2017
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria (those who meet all of the following are eligible)

  1. Patients requiring diagnostic colonoscopy with an estimated examination time ≤ 30 min; males and females, ASA grade I-II, between 18 and 65 years old (inclusive);
  2. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
  3. Respiratory rate between ≥ 10 and ≤ 24 breaths per minute; SpO2 when inhaling > 95%; SBP ≥ 90 mmHg; DBP ≥ 60 mmHg; heart rate between ≥ 50 and ≤ 100 beats per minute;
  4. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.

Exclusion Criteria (those who meet any one of the following are ineligible):

  1. Patients having contraindications to general anesthesia or previous history of anesthesia accidents;
  2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated;
  3. Patient received any of the following drugs or therapies prior to screening:
  4. Participated in other drug clinical trials within 3 month prior to screening;
  5. In receipt of propofol and/or opioid analgesics within 1 month prior to screening;
  6. 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.
  7. Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:
  8. ANC ≤ 1.5 x 109/L;
  9. PLT ≤ 80 x 109/L;
  10. Hb ≤ 90 g/L (no blood transfusion within the last 14 days);
  11. AST and ALT ≥ 2.5 x ULN;
  12. TBIL ≥ 1.5 x ULN;
  13. Creatinine ≥ 1.5 x ULN.
  14. History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);
  15. History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);
  16. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Patients who are planning pregnancy within 1 month after the completion of the trial (including male patients);
  17. Potential difficult airway or difficult tracheal intubation, as determined by the investigator, and/or history of intubation failure;
  18. Patients determined by the investigator to be unsuitable for participating in this trial for any reason.

Trial locations and contacts

1 site in 1 country.

China1 site
  • West China Hospital, Sichuan University

    Chengdu, Sichuan

Other trials in China

About this study

Official title: A Phase IIa, Multi-center, Open-label, Non-randomized, Active-controlled, and Dose-escalation Clinical Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion for Sedation/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
Colonoscopy
Being tested
HSK3486, Propofol

What participants receive

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

  • HSK3486Drug

    For induction and maintenance of sedation.

  • PropofolDrug

    For induction and maintenance of sedation.

Study groups in NCT03773042
Study groupRoleWhat they receive
HSK3486Experimental0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg
Receives: Drug: HSK3486
PropofolActive comparator1.0mg/kg, 2.0mg/kg
Receives: Drug: Propofol

What is being measured

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

  1. Rate of successful colonoscopies.

    Measured: From the first dose of the study drug to removal of colonoscope on day 1

Secondary outcomes (6)
  1. Insertion time

    Measured: From the first dose of study drug until insertion of colonoscope on day 1

  2. 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

  3. 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

  4. Time to discharge

    Measured: From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1

  5. Application of study drug and alternative medication

    Total dosages of study drug and alternative medication

    Measured: During the colonoscopy procedure on day 1

  6. Mini-Mental State Examinations (MMSE)

    Measured: During the screening and 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.

  1. First posted12 Dec 2018
  2. Study startDec 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773042
Sponsor's protocol ID
HSK3486-201
Status last verified
Jun 2017
First submitted
6 Dec 2018
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK3486 and Propofol in people with Colonoscopy, 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?

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 13 Dec 2018. 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 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?

Rate of successful colonoscopies. (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 13 Dec 2018.

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