SedationPhase 3NCT03779061
Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy
A Phase 3 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 evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sedation
- What is being tested?
- Remimazolam Tosilate and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2018to 28 Sep 2018
- Phase
- Phase 3
- 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
Who may be able to join
- subjects aged 18-65 years；
- intending to undergo colonoscopy;
- ASA( American Society of Anesthesiologists) I or II；
- 18 kg/m²<BMI(Body Mass Index)<30 kg/m²;
- the operation time of gastroscopy is not more than 30 min；
- Signed informed consent.
Who cannot join
- Patients need to be Complicated colonoscopy;
- Patients need to be Tracheal intubation;
- Patients with respiratory management difficulties (Modified Mallampati grade IV）;
- one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
- allergic to drugs used in the study;
- pregnant women or those in lactation period
- The subject has participated in other clinical trial within the 3 months prior to randomization.
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical trial Ethnics Committee of Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010
About this study
Official title: A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Colonoscopy
The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.
Read the detailed description
This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted before colonoscopy. 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 | Experimental | Not described Receives: Drug: Remimazolam Tosilate |
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of successful sedation
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy
Measured: approximately 3 hours
Secondary outcomes (4)
Sedation induction time
Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S（The Observer's Assessment of Alertness/Sedation Scale） ≤ 3.
Measured: approximately 3 hours
Sedation recovery time
Sedation induction time is defined as from stop of study drug injection to be wide awake.
Measured: approximately 3 hours
rate of hypotension
rate of hypotension as measured by the proportion of subjects who experienced hypotension
Measured: approximately 3 hours
rate of respiratory depression
rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression
Measured: approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start28 Jun 2018
- Primary completion20 Sep 2018
- Study completion28 Sep 2018
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 388 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
- NCT03779061
- Sponsor's protocol ID
- HR-RMZL-Ⅲ-PEC
- Status last verified
- Jul 2018
- First submitted
- 16 Dec 2018
- Last updated
- 19 Dec 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 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT03779061
- Acronym / sponsor ID
- HR-RMZL-Ⅲ-PEC
- Conditions
- Sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 19 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.
The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing colonoscopy.
Detailed description
This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate | Experimental | Drug: Remimazolam Tosilate |
| Propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects aged 18-65 years；
- intending to undergo colonoscopy;
- ASA( American Society of Anesthesiologists) I or II；
- 18 kg/m²<BMI(Body Mass Index)<30 kg/m²;
- the operation time of gastroscopy is not more than 30 min；
Key exclusion criteria (8 listed)
- Patients need to be Complicated colonoscopy;
- Patients need to be Tracheal intubation;
- Patients with respiratory management difficulties (Modified Mallampati grade IV）;
- one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
- A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
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 |
| PropofolInitial dose plus supplemental doses as necessary | Drug | Propofol |
Primary outcome
rate of successful sedation
Time frame: approximately 3 hours
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy
4 secondary outcomes
Sedation induction time
Time frame: approximately 3 hours
Sedation recovery time
Time frame: approximately 3 hours
rate of hypotension
Time frame: approximately 3 hours
rate of respiratory depression
Time frame: approximately 3 hours
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 19 Dec 2018.
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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 3 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 6 inclusion and 8 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 19 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 sedation (time frame: approximately 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 19 Dec 2018.