SedationPhase 2NCT03003884
A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
A Phase 2 study testing Remimazolam Tosilate and Propofol in people with Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sedation
- What is being tested?
- Remimazolam Tosilate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subjects aged 18-60 years；
- intending to undergo diagnostic upper GI endoscopy
- American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；
- 18 kg/m²<BMI(Body Mass Index)<30 kg/m².
Who cannot join
- Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;
- one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
- history of severe cardiovascular disease;
- cerebral disease or mental disorder;
- allergic to drugs used in the study;
- pregnant women or those in lactation period
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Union Medical College Hospital
Beijing, Beijing Municipality
About this study
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.
Read the detailed description
This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
Initial dose plus supplemental doses as necessary.
PropofolDrug
Initial dose plus supplemental doses as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate 1 | Experimental | IV of Remimazolam Tosilate at 5mg for initial dose Receives: Drug: Remimazolam Tosilate |
| Remimazolam Tosilate 2 | Experimental | IV of Remimazolam Tosilate at 7mg for initial dose Receives: Drug: Remimazolam Tosilate |
| Remimazolam Tosilate 3 | Experimental | IV of Remimazolam Tosilate at 8mg for initial dose Receives: Drug: Remimazolam Tosilate |
| Remimazolam Tosilate 4 | Experimental | IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected. Receives: Drug: Remimazolam Tosilate |
| Propofol | Active comparator | IV of Propofol at 1.5mg/kg for initial dose Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
Measured: From start of study drug injection to patient discharge (approx. 3 hours)
Secondary outcomes (5)
recovery time as measured by time
Measured: After the last of study drug injection to patient discharge (approx. 3 hours)
rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy
Measured: From start of study drug injection to patient discharge (approx. 3 hours)
rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy
Measured: From start of study drug injection to patient discharge (approx. 3 hours)
rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy
Measured: From start of study drug injection to patient discharge (approx. 3 hours)
pain on injection was assessed by the patient immediately after administration of the study drug
Measured: 1-10 minutes (from the beginning of sedation )]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 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
- NCT03003884
- Sponsor's protocol ID
- HR-RMZL-IIc-UGE
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
- ClinicalTrials.gov ID
- NCT03003884
- Acronym / sponsor ID
- HR-RMZL-IIc-UGE
- Conditions
- Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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 find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.
Detailed description
This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate 1 | Experimental | Drug: Remimazolam TosilateIV of Remimazolam Tosilate at 5mg for initial dose |
| Remimazolam Tosilate 2 | Experimental | Drug: Remimazolam TosilateIV of Remimazolam Tosilate at 7mg for initial dose |
| Remimazolam Tosilate 3 | Experimental | Drug: Remimazolam TosilateIV of Remimazolam Tosilate at 8mg for initial dose |
| Remimazolam Tosilate 4 | Experimental | Drug: Remimazolam TosilateIV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected. |
| Propofol | Active comparator | Drug: PropofolIV of Propofol at 1.5mg/kg for initial dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subjects aged 18-60 years；
- intending to undergo diagnostic upper GI endoscopy
- American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；
- 18 kg/m²<BMI(Body Mass Index)<30 kg/m².
Key exclusion criteria (7 listed)
- Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;
- one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
- history of severe cardiovascular disease;
- cerebral disease or mental disorder;
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 TosilateInitial dose plus supplemental doses as necessary. | Drug | Remimazolam Tosilate 1, Remimazolam Tosilate 2, Remimazolam Tosilate 3, Remimazolam Tosilate 4 |
| PropofolInitial dose plus supplemental doses as necessary. | Drug | Propofol |
Primary outcome
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
Time frame: From start of study drug injection to patient discharge (approx. 3 hours)
5 secondary outcomes
recovery time as measured by time
Time frame: After the last of study drug injection to patient discharge (approx. 3 hours)
rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy
Time frame: From start of study drug injection to patient discharge (approx. 3 hours)
rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy
Time frame: From start of study drug injection to patient discharge (approx. 3 hours)
rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy
Time frame: From start of study drug injection to patient discharge (approx. 3 hours)
pain on injection was assessed by the patient immediately after administration of the study drug
Time frame: 1-10 minutes (from the beginning of sedation )]
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 8 Sep 2017.
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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 2 study testing Remimazolam Tosilate and Propofol in people with Sedation, run by Jiangsu HengRui Medicine 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 4 inclusion and 7 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 8 Sep 2017. 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?
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy. (time frame: From start of study drug injection to patient discharge (approx. 3 hours)). 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 8 Sep 2017.