A Phase 3 Study of MR13A11A

Phase 3

Completed

• Conditions: Patients who require at least 6 hours or more mechanical ventilation under intensive care and require analgesics.

• Registration Number: JPRN-jRCT2080224954
• Lead Sponsor: Maruishi Pharmaceutical Co., Ltd.

Brief Summary

The results of this study showed that the efficacy of continuous intravenous administration of remifentanil for analgesia in patients requiring respiratory management in intensive care was not inferior to that of fentanyl. The safety profile of remifentanil did not differ from that of fentanyl, and remifentanil rapidly eliminated from the arterial blood upon completion of administration. Remifentanil is expected to be a safe narcotic analgesic that can be used in the analgesic management in intensive care.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-19
• Study Completion: 2021-08-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

1) Patients aged 20 years or older (at the time of signing informed consent).
2) Patients or his/her legal representative providing written informed consent for study participation in person.
3) Patients who is expected to require more than 6 hrs and less than 10 days of respiratory management with intubation under intensive care and are anticipated to require pain relief.
4) Patients who need postoperative ICU management: ASA I to III at the post-operative diagnosis.
5) If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.

Exclusion Criteria

1) Patients with severe damage on the central nervous system.
2) Patients who are judged by investigator or sub-investigator to have a neurological disease that will make pain/sedation assessment difficult.
3) Patients who are contraindicated to opioid analgesics, or patients who are suspected to cause allergic reactions to concomitant medications during the study period.
4) Patients with any history of hypersensitivities to fentanyl products or to any of the ingredients of the study drug
5) Patients who received Nalmefene hydrochloride hydrate within 1 week prior to the study drug administration, or patients who expected to receive Nalmefene hydrochloride hydrate during the study drug administration.
6) Patients who require local anesthetic, epidural or intrathecal administration of analgesics, or nerve block.
7) Patients with contraindicated to muscle relaxant.
8) Patients who likely to cause respiratory depression, such as coma due to head injury or brain tumor.
9) Patients with history of seizure.
10) Patients with asthma.
11) Patients with concurrent or previous drug abuse.
12) Patients with concurrent or previous alcoholism.
13) Patients with a history of severe drug hypersensitivity.
14) Patients who received treatment with any study drug or medical device in a clinical study within 4 months prior to the informed consent procedure, or who are planning to participate in another clinical study before the end of this study.
15) Patients who received treatment with any study drug in a clinical research within 4 months prior to the informed consent procedure, or who are planning to participate in another clinical research before the end of this study.
16) Patients who judged serious status, which may cause death within 24 hours.
17) Patients who are not able to comply with all procedures prescribed in the protocol.
18) Patients with massive bleeding and are considered reoperation.
19) In the Investigators or subinvestigators opinion, patients who are assessed inappropriate to participate this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified