Sedation in the Upper Gastrointestinal EndoscopyPhase 4NCT06169995
A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy
A Phase 4 study testing Remimazolam Tosilate in people with Sedation in the Upper Gastrointestinal Endoscopy, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation in the Upper Gastrointestinal Endoscopy
- What is being tested?
- Remimazolam Tosilate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesChina
- Study dates
- 11 Dec 2023to 16 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients or their guardians are able to provide a written informed consent
- participants undergo upper gastrointestinal endoscopy
- ≥18 years old, male or female
- 18 kg/m2≤bmi≤30kg/m2
Who cannot join
- Subjects to be intubated (including laryngeal mask placement);
- Complex endoscopic diagnosis and treatment operations are required;
- Severe cardiovascular disease within 6 months prior to signing the ICF;
- Heart rate < 50 beats/min during screening period;
- Subjects with poor blood pressure control during screening;
- Severe arrhythmias or heart disease; the circulatory system is unstable;
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- Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
- Subjects with a history of drug abuse;
- Abnormal values of the laboratory examination;
- Allergic to relevant drugs ingredient or component;
- Pregnant or nursing women;
- Subjects who has participated in clinical trials of other interventions recently;
- Other conditions deemed unsuitable to be included.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, 550000
About this study
Official title: A Multi-center, Open-label，Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in Upper Gastrointestinal Endoscopy
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy
- Being tested
- Remimazolam Tosilate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
bolus dose: 5mg，IV supplemental dose: 2.5mg，IV
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate for Injection | Experimental | Not described Receives: Drug: Remimazolam Tosilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy
Measured: on Day1
Secondary outcomes (5)
Percentage of subjects receiving supplemental dose for sedation
Measured: on Day1
The number of supplemental doses of the research drug
Measured: on Day1
Wake-up time.
Measured: on Day1
Incidence of sedation hypotension.
Measured: on Day1
Incidence of respiratory depression
Measured: on Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start11 Dec 2023
- Primary completion15 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in the Upper Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169995
- Sponsor's protocol ID
- HR7056-402
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label，Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06169995
- Acronym / sponsor ID
- HR7056-402
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 14 Dec 2023 (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.
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate for Injection | Experimental | Drug: Remimazolam Tosilate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients or their guardians are able to provide a written informed consent
- participants undergo upper gastrointestinal endoscopy
- ≥18 years old, male or female
- 18 kg/m2≤bmi≤30kg/m2
Key exclusion criteria (13 listed)
- Subjects to be intubated (including laryngeal mask placement);
- Complex endoscopic diagnosis and treatment operations are required;
- Severe cardiovascular disease within 6 months prior to signing the ICF;
- Heart rate < 50 beats/min during screening period;
- Subjects with poor blood pressure control during 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 |
|---|---|---|
| Remimazolam Tosilatebolus dose: 5mg，IV supplemental dose: 2.5mg，IV | Drug | Remimazolam Tosilate for Injection |
Primary outcome
Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy
Time frame: on Day1
5 secondary outcomes
Percentage of subjects receiving supplemental dose for sedation
Time frame: on Day1
The number of supplemental doses of the research drug
Time frame: on Day1
Wake-up time.
Time frame: on Day1
Incidence of sedation hypotension.
Time frame: on Day1
Incidence of respiratory depression
Time frame: on Day1
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 29 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam Tosilate in people with Sedation in the Upper Gastrointestinal Endoscopy, run by Jiangsu HengRui Medicine Co., Ltd. at 2 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 4 inclusion and 13 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage(%) of paticipants who experienced successful sedation in Upper Gastrointestinal Endoscopy (time frame: on Day1). 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 29 Dec 2023.