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.
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)
- 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);
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
- 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;
- 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):
- Patients having contraindications to general anesthesia or previous history of anesthesia accidents;
- Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated;
- Patient received any of the following drugs or therapies prior to screening:
- Participated in other drug clinical trials within 3 month prior to screening;
- In receipt of propofol and/or opioid analgesics within 1 month prior to screening;
- 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.
- Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:
- ANC ≤ 1.5 x 109/L;
- PLT ≤ 80 x 109/L;
- Hb ≤ 90 g/L (no blood transfusion within the last 14 days);
- AST and ALT ≥ 2.5 x ULN;
- TBIL ≥ 1.5 x ULN;
- Creatinine ≥ 1.5 x ULN.
- History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);
- History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);
- 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);
- Potential difficult airway or difficult tracheal intubation, as determined by the investigator, and/or history of intubation failure;
- 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.
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 group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg Receives: Drug: HSK3486 |
| Propofol | Active comparator | 1.0mg/kg, 2.0mg/kg Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful colonoscopies.
Measured: From the first dose of the study drug to removal of colonoscope on day 1
Secondary outcomes (6)
Insertion time
Measured: From the 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 MOAA/S scores of 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
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.
- First posted12 Dec 2018
- Study startDec 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03773042
- Acronym / sponsor ID
- HSK3486-201
- Conditions
- Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Dec 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg |
| Propofol | Active comparator | Drug: Propofol1.0mg/kg, 2.0mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HSK3486For induction and maintenance of sedation. | Drug | HSK3486 |
| PropofolFor induction and maintenance of sedation. | Drug | Propofol |
Primary outcome
Rate of successful colonoscopies.
Time frame: From the first dose of the study drug to removal of colonoscope on day 1
6 secondary outcomes
Insertion time
Time frame: From the 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 MOAA/S scores of 9 on day 1
Application of study drug and alternative medication
Time frame: During the colonoscopy procedure on day 1
Mini-Mental State Examinations (MMSE)
Time frame: During the screening and 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 13 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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 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.