A Phase II/III Investigator Initiated Clinical Traial Evaluating the Efficacy and Safety of Remimazolam in Japanese Patients Undergoing Gastrointestinal Endoscopy

JRCT ID: jRCT2031200360

Registered date:15/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Japanese patients undergoing upper gastrointestinal endoscopy or colonoscopy without analgesics
• Date of first enrollment: 09/05/2021
• Target sample size: 150
• Study type: Interventional

Intervention(s)

Dose-finding step
Remimazolam is administered at the following doses
Cohort 1: Initial dose 2 mg Additional dose 1 mg / dose
Cohort 2: Initial dose 3 mg Additional dose 1 mg / dose
Cohort 3: Initial dose 5 mg Additional dose 2 mg / dose

Verification step
Remimazolam group: the dose determined in the dose-finding step
Placebo group: the dose determined in the dose-finding step

Outcome(s)

Primary Outcome

Success rate of sedation in gastrointestinal endoscopy
The percentage of subjects who meet the criteria for success in the analysis target population is defined as "success" when all of the following are satisfied.
1 Sedation (MOAA / S score 4 or less) can be obtained before the start of endoscopy.
2 Successful gastrointestinal endoscopy
3 The number of additional doses does not exceed 2 times per 6 minutes for upper gastrointestinal examination and 5 times per 15 minutes for colonoscopy.

Secondary Outcome

Effectiveness
1 Percentage of subjects who achieved sedation (MOAA / S score of 4 or less) before the start of endoscopy
2 Time from initial administration of investigational drug to sedation (MOAA / S score of 4 or less)
Optimal dose of investigational drug until sedation (MOAA / S score of 4 or less) is obtained (total of initial dose and additional dose)
4 Time from the end of the endoscope to walking (walking without swaying a 5m straight line)
5 Time from the final administration of the investigational drug to walking (walking without swaying a 5 m straight line)
6 Patient satisfaction evaluation (5-grade evaluation)
7 Satisfaction evaluation by doctor (5-grade evaluation)

Safety assessment
1. Adverse events
2. Laboratory tests (hematological tests, blood biochemical tests and urine tests)
3. Vital signs (blood pressure, heart rate, respiratory rate), SpO2
4. ECG examination (12-lead ECG, monitor ECG)
5. Presence or absence of vascular pain
6. Evaluation of arousal (presence or absence of resedation after awakening [from the end of investigational drug administration to the time of leaving the room], presence or absence of wobbling / falling [from after leaving the room to returning home / from returning home to going to bed])
7. With or without urgent flumazenil administration
8. Presence or absence of resedation in patients receiving flumazenil
9. Presence or absence of loss of consciousness
10. With or without oxygen administration
11. Whether or not manual ventilation is performed
12. Whether or not an emergency response is provided by a doctor other than the endoscopist

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Dose-finding step
1The age at the time of obtaining consent is 20 to 74 years old
2 ASA classification is I or II
3 Weight 45kg or more and 70kg or less, BMI less than 30
Verification step
1 The age at the time of obtaining consent is 20 years or older
2 BMI is less than 30

Exclude criteria

Dose-finding step and verification step
1 Alcohol polydipsia (60g or more per day in terms of pure alcohol)
2 Those who regularly use benzodiazepines
3 Those who regularly use analgesics
4 Those with severe mental disease
5 Those with a history of abdominal surgery
6 Those with severe respiratory disease
7 SpO2 95% (room air)
8 Mallampati classification III or higher
9 Those with essential hypotension
10 Among the clinical test measurement values at the time of screening, those that correspond to any of the following
AST value: 2.5 times or more of the facility standard value upper limit
ALT value: 2.5 times or more of the upper limit of the facility standard value
Total bilirubin value: 1.5 times or more of the upper limit of facility standard value

Related Information

• Primary Sponsor: Ikehara Hisatomo
• Secondary Sponsor: Mundipharma K.K