A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice

February 23, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Domestic, Prospective, Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice

This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients receiving remazolam toluenesulfonate for painless gastroscopy and colonoscopy

Description

Inclusion Criteria:

  1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
  2. Patients need to sign informed consent

Exclusion Criteria:

  1. Patients who are participating in or planning to participate in any interventional clinical trial
  2. The investigator considers that there are any other reasons for the patient's ineligibility for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Painless gastroscopic sedation cohort
Drug: Remimazolam Tosilate for Injection
Remimazolam Tosilate for Injection
Cohort 2
Painless colonoscopy sedation cohort
Drug: Remimazolam Tosilate for Injection
Remimazolam Tosilate for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Within 3 days of receiving gastroscopy and colonoscopy
Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE
Within 3 days of receiving gastroscopy and colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious adverse events
Time Frame: Within 3 days of receiving gastroscopy and colonoscopy
Refer to SAE definition standards
Within 3 days of receiving gastroscopy and colonoscopy
Adverse drug reactions
Time Frame: Within 3 days of receiving gastroscopy and colonoscopy
By evaluating the association of adverse events with drugs
Within 3 days of receiving gastroscopy and colonoscopy
Injection pain questionnaire
Time Frame: Within 3 days of receiving gastroscopy and colonoscopy
By observing and asking
Within 3 days of receiving gastroscopy and colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ARMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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