A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised

Condition(s) targeted: Anesthesia

Intervention: Remifentanil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.

Official title: An Open-Label Study to Evaluate the Efficacy and Safety of JNJ-268229 in Pediatric Subjects General Anesthetised

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with positive response to skin incision

Secondary outcome:

Hemodynamics stability

Drugs used to deal with insufficient anesthesia (inadequate anesthesia) or excessive anesthesia

Assessment on analgesic effect

Total dose level of remifentanil

Total concomitant anesthetic dose level

Time from completion of anesthesia to resumption of spontaneous respiration

Time until arrival of Steward Postanesthetic Recovery Score at 6

Time from completion of anesthesia to discharge from the recovery room

Respiratory stability

Detailed description: This is multicenter, open-label (identity of assigned study drug will be known) one-arm study in pediatric participants receiving general anesthesia. The participants are children aged 1-15 years old, planned to undergo head and neck, thoracic (except heart), urological, orthopedic or plastic surgery. Approximately 80 participants will be enrolled in this study. These participants are divided into two groups by age (1-6 and 7-15 years old). Pharmacokinetic (what the body does to the drug,) blood samples will be collected from at least 3 participants between the ages of 1 and 6 years and at least 3 participants between the ages of 7 and 15 years from 15 minutes after the start of infusion to the end of infusion of the study drug . The study consists of 4 phases: screening phase, treatment phase, recovery phase and follow-up phase. Screening for eligible participants will be performed within 14 days before administration of the study drug. The safety and tolerability of study drug will be evaluated by physical examinations, electrocardiogram (ECG), clinical laboratory tests, vital signs, and adverse events (AEs) according to the Time and Events Schedule. Participants safety will be monitored throughout the study.

Minimum age: 1 Year. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants scheduled to receive surgery under general anesthesia, necessitating

airway securing with tracheal intubation and analgesia with opioid analgesics

- American Society of Anesthesiologists (ASA) Physical Status Classification is I or II

at the time of operation planning

- Participants scheduled to receive operations estimated to take 30 minutes or more

from skin incision i. e. Head and neck, thoracic (except heart), intraperitoneal, ophthalmological, otorhinolaryngological, urological, orthopedic or plastic surgery

- Girls having undergone menarche are eligible only if the urine pregnancy test at the

time of screening is negative Exclusion Criteria:-

- Chronic use of opioid analgesics or their use within 12 hours before the planned

start of general anesthesia - Hypersensitivity to opioid analgesics or local

anesthetics

- History of jaundice or unexplained fever induced by halogenated anesthetics

- Unstable hemodynamics (eg. congenital heart disease, congenital diaphragmatic hernia)

Ideal body weight is not within the 10th to 90th percentile received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study drug or is currently enrolled in an investigational study

Asahikawa, Japan

Kobe, Japan

Kure, Japan

Kurume, Japan

Ohmura, Japan

Osaka, Japan

Shimajiri, Japan

Shimotsuke, Japan

Tokyo, Japan

Starting date: November 2013
Last updated: December 2, 2014