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AnesthesiaPhase 3NCT01998165

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

A Phase 3 study testing Remifentanil in people with Anesthesia, run by Janssen Pharmaceutical K.K. at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 15 years
Conditions the study is for
Anesthesia
What is being tested?
Remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
9 sitesJapan
Study dates
Nov 2013to Nov 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Study site

    Asahikawa

  • Study site

    Kobe

  • Study site

    Kure

  • Study site

    Kurume

  • Study site

    Ohmura

  • Study site

    Osaka

  • Study site

    Shimajiri

  • Study site

    Shimotsuke

  • Study site

    Tokyo

Other trials in Japan

About this study

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

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.

Read the 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.

Conditions
Anesthesia
Being tested
Remifentanil
Keywords
Anesthesia, Remifentanil, Ultiva

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemifentanilDrug

    Also called remifentanil hydrochloride (JNJ-268229)

    After intubation, continuous intravenous infusion of remifentanil (0.25 µg/kg/min) is started, while anesthesia is maintained with inhaled or intravenous anesthetics. In cases where sedation by general anesthetics and analgesia by lidocaine does not seem to provide a sufficient means of analgesia at the time of intubation, remifentanil may be used, beginning before intubation. The rate of infusion may be adjusted while monitoring the subject's general condition in 25% to 100% increments or in 25% to 50% decrements every 2 to 5 minutes, but should not exceed 1.3 µg/kg/min.

Study groups in NCT01998165
Study groupRoleWhat they receive
Remifentanil (0.25 µg/kg/min)ExperimentalNot described
Receives: Drug: Remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with positive response to skin incision

    Positive response is defined by the presence of at least one of below listed conditions: Heart rate increased >20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for >1 minute); Systolic blood pressure increased >20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for >1 minute; Gross movement, swallowing, eye opening (if there are patches on the eyes, this assessment might be not evaluated) or grimacing and sweating, lachrymation or mydriasis.

    Measured: 5-minute assessment period after skin incision

Secondary outcomes (9)

  1. Hemodynamics stability

    Heart Rate and Blood Pressure increased >20% above baseline that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision for less than or equal to 1 minute.

    Measured: 5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

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

    The time interval between completion of anesthesia and extubation is calculated based on both the time upon completion of general anesthesia and the time upon completion of extubation and recorded.

    Measured: Time interval between completion of anesthesia and extubation

  3. Assessment on analgesic effect

    Assess an analgesic effect of JNJ-268229 during operation on 3-point ranging from "effective / not effective / undeterminable" generally.

    Measured: 240 minutes after completion of anesthesia

  4. Total dose level of remifentanil

    The overall use (including dose increase/decrease, time of dose increase/decrease and start time of single supplemental bolus injection, etc) of remifentanil will be recorded.

    Measured: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

  5. Total concomitant anesthetic dose level

    The overall use (drug name, dose and start time, etc) of the inhaled or intravenous anesthetics used for general anesthesia

    Measured: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

  6. Time from completion of anesthesia to resumption of spontaneous respiration

    The time taken from completion of anesthesia to resumption of spontaneous respiration is calculated based on both the time upon completion of general anesthesia and the time upon confirmation of resumed spontaneous respiration and recorded.

    Measured: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

  7. Time until arrival of Steward Postanesthetic Recovery Score at 6

    Recovery Score is rated as Consciousness,Airway and Movement

    Measured: 240 minutes after completion of anesthesia or skin closure

  8. Time from completion of anesthesia to discharge from the recovery room

    Anesthesia is calculated based on both the time upon completion of general anesthesia and the time upon discharge from the operating /recovery room.

    Measured: 240 minutes after completion of anesthesia or skin closure

  9. Respiratory stability

    Heart Rate and Blood Pressure increased >20% above baseline that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision for less than or equal to 1 minute.

    Measured: 5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01998165
Sponsor's protocol ID
CR102524
Other IDs
ULTIVAANS3001
Status last verified
Nov 2015
First submitted
15 Nov 2013
Last updated
16 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remifentanil in people with Anesthesia, run by Janssen Pharmaceutical K.K. at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with positive response to skin incision (time frame: 5-minute assessment period after skin incision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01998165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.

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