An Open-Label Evaluation of Safety of the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40 µg)] for Management of Acute Post- Operative Pain in Pediatric Patients

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001173-14-GB
• Date of registration: 28/05/2008
• Prospective Registration: Yes
• Primary sponsor: Janssen Cilag International N.V.,
• Public title: An Open-Label Evaluation of Safety of the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40 µg)] for Management of Acute Post- Operative Pain in Pediatric Patients
• Scientific title: An Open-Label Evaluation of Safety of the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40 µg)] for Management of Acute Post- Operative Pain in Pediatric Patients
• Date of first enrolment: 11/11/2008
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001173-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

France, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
·In patients, age 6 to 17 years, male or female, or females of childbearing
·potential with a negative pregnancy test after admission to the hospital.
·Patients capable of understanding and cooperating with the requirements
of the study and operating the IONSYS system.
·ASA physical status I, II or III
·Patients whose parent(s) or guardian(s) have/has signed and dated an
informed consent for the patient to participate in the study.
·Patients who have provided written assent to participate in the study.
.Patient Body weight of at least 40.0 kg

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
·Patients who have undergone any surgery on the airway, head or neck.
·Patients who received an extended release opioid (e.g., DepoDur®) within
48 hours prior to Hour 0 or who are expected to have post-operative
analgesia supplied by a continuous regional technique or patient
controlled epidural analgesia.
·Patients with a history of allergy or hypersensitivity to fentanyl, skin
adhesives, and/or cetylpyridinium chloride.
·Patients who are expected to require intensive care.
·Patients who will likely require additional surgical procedures within 36 hours




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The management of acute postoperative pain in hospitalized paediatric patients.
MedDRA version: 9.1 Level: LLT Classification code 10033371 Term: Pain

Intervention(s)

Trade Name: IONSYS 40 micrograms per dose iontophrectic transdermal system
Pharmaceutical Form: Iontophoretic transdermal system
INN or Proposed INN: Fentanyl HCL
CAS Number: 1443-54-5
Other descriptive name: Propanamide, N-phenyl-N- [1-(2-phenylethyl)-4-piperidinyl]-, monohydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10.8-

Primary Outcome(s)

Secondary Objective: The secondary objectives of the study are the evaluation of clinical utility and pharmacokinetics of the IONSYS system for the management of postoperative pain in paediatric patients

Primary end point(s): Safety: Oxygen saturation, vital signs (systolic/diastolic blood pressure, heart rate,
temperature and respiratory rate), adverse events (AEs), and application site reactions(ASRs).
Clinical Use: Patients will be assessed periodically for pain intensity using a color
visual analog rating scale from 0 (no pain) to 10 (worst possible pain). Patient, parent or guardian, and investigator global assessments will be performed at the completion of each 24-hour IONSYS™ treatment period. The estimated number of IONSYS™doses used in each 24-hour period and the amount of supplemental analgesia administered after system application will be recorded. A study physician assessment of the patient’s ability to use the IONSYS™ system will be completed at the time of study treatment termination.
Fentanyl Concentration: Up to a total of five blood samples will be drawn from each
patient to determine the fentanyl concentration at the following approximate time
points: Hour 0 (pre-application) and Hours 3, 6, 12, and 24 following IONSYS™
application.

Main Objective: The main objective of the study is to evaluate the safety of the
IONSYS system for the management of postoperative pain in paediatric patients

Secondary ID(s)

C-2006-007-01

2008-001173-14-FR