A Phase II/III Study of MR19A13A.

JRCT ID: jRCT2031220417

Registered date:27/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients undergoing a scheduled surgery under general anesthesia.with mask induction.
• Date of first enrollment: 30/11/2022
• Target sample size: 72
• Study type: Interventional
• Intervention(s): MR19A13A is administered orally in one swallowing motion as possible.

Outcome(s)

• Primary Outcome: Proportion subjects achieving a sedation score of 3 or higher within 30 minutes after completion of study drug administration.
• Secondary Outcome: Proportion of subjects achieving a anxiety score of 3 or higher within 30 minutes after completion of study drug administration.

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 16age old
• Gender: Both

Include criteria

1) Japanese Patients aged from 6 months to 16 years, at the time of informed consent.
2) Patients with written consent from their legal representatives; If the patient is over 7 years, it is desirable to obtain the assent also from the patient as possible.

Exclude criteria

1) Patients with the history of hypersensitivity or suspected hypersensitivity to any ingredients of the study drug.
2) Patients with acute angle-closure glaucoma.
3) Patients with myasthenia gravis.
4) Patients receiving the drug containing HIV protease inhibitors, efavirenz, or cobicistat.
5) Patients receiving St. John's wort supplement and are unable to discontinue taking the supplement from 1 week prior to the start of study drug administration up to 8 hours after the completion of study drug administration.
6) Patients with moderate to severe cerebral palsy.
7) Patients with other central nervous system disorders including poorly controlled convulsive disorders, spasm within 1 week prior to the day of administration, a history or possible history of increased intracranial pressure, or known psychiatric disorders that may exacerbate normal response to sedative medications (Patients who have had one episode of febrile convulsion in the past will not be excluded).
8) Patients using or expected to use artificial heart-lungs during the surgery.
9) Patients expected to receive blood transfusion during or after the surgery (up to 8 hours after completion of the study drug administration).
10) Patients who have received the drug that may interfere with sedation evaluation within 8 hours prior to the start of study drug administration.

Related Information

• Primary Sponsor: Nobuyo Oya