A Phase III Investigator Initiated Clinical Trial Evaluating the Efficacy and Safety of CNS7056 (Remimazolam) With a Concomitant Use of Opioid Analgesics in Japanese Patients Undergoing Gastrointestinal Endoscopy

Phase 3

• Conditions: Japanese patients undergoing gastrointestinal endoscopy in combination with a concomitant use of opi

• Registration Number: JPRN-jRCT2031220129
• Lead Sponsor: Ikehara Hisatomo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Japanese patients who are scheduled to undergo interventional endoscopy of the upper gastrointestinal tract (oral), large intestine, hepato-biliary-pancreas, or small intestine under the concomitant use of pethidine hydrochloride or pentazocine
2. The age at the time of obtaining consent is 20 years or older
3. BMI is less than 30kg/m2
4. Those whose planned procedure time (from scope insertion to final removal) that is determined by principal investigator or sub-investigator to be longer than 15 minutes
5. Those who can be hospitalized for at least 3 days from the day before the endoscopy to the day after the endoscopy

Exclusion Criteria

1. Those who regularly use benzodiazepines (due to insomnia, anxiety, spasm, epilepsy, and others) or those who have tolerance to benzodiazepines
2. Those who regularly use analgesics including opioid analgesics (except low-dose aspirin for preventing thrombosis)
3. Those with a history of hypersensitivity to benzodiazepines, opioid analgesics, opioid antagonists (naloxone, levallorphan, and others), or flumazenil, or those with diseases or symptoms that contraindicate the administration of these drugs
4. Alcohol polydipsia (60g or more per day in terms of pure alcohol) or those with complications or a history of alcohol dependence
5. Those with a history of abdominal surgery and who are expected to have difficulty for scope insertion
6. Those with severe respiratory disease or essential hypotension
7. Among the clinical test measurement values within 28 days prior to administration of investigational drug, those that correspond to any of AST, ALT, and total bilirubin values that are 2.5 times or more of the upper limit of standard value (5 times or more in the case of patients undergoing hepato-biliary-pancreatic endoscopy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified