E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The management of acute postoperative pain in hospitalized paediatric patients. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033371 |
E.1.2 | Term | Pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the study is to evaluate the safety of the IONSYS system for the management of postoperative pain in paediatric patients |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
the adhesion of each IONSYS system |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |