E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute, moderate to severe postoperative pain after elective surgery in a hospital setting in patients needing at least 24 hours strong opioids for pain therapy. |
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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 | 10054711 |
E.1.2 | Term | Postoperative 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 |
Subject's overall assessment of pain treatment method of the last 24 hours. |
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E.2.2 | Secondary objectives of the trial |
- Subject´s, physician´s and staff´s global assessment at additional time-points - Current pain intensity rating - Number of hours per day with maintained "comfort level" (NRS*≤ 4) - Evaluation of the post-operative progress of the patient every 24 hrs in regard of: . time out of bed . time to mobilisation - Well beeing during the post-operative phase (PPP33®-questionaire) - Physiotherapy ability - Safety and tolerability of IONSYS as a hospital’s treatment option - Comprehensibility of the information material |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 18 years or more; male or female 2. American Society of Anesthesiology (ASA) pre-operative physical status I, II or III 3. Expected hospitalization of at least 24 hours 4. Expected moderate to severe pain requiring treatment with parenteral opioids of at least 24 hrs. following major elective surgery 5. Subject's capability to operate the iontophoretic transdermal system, under- standing of the requirements of the clinical study and willingness to cooperate 6. Written Informed Consent, signed and dated during the pre-operative phase 7. Compliance with the following criteria in the recovery room after an elective major surgery requiring a parenteral opioid treatment for at least 24 hours: · General anesthesia . Spinal anesthesia of ≤ 4 h action time or . Epidural anesthesia . Epidural anesthesia Epidural or local anesthesia: only when the administered analgesic was short- lasting and given only for the period of surgery and not for the period in the recovery room. 8. Alertness for at least 30 min. and spontaneous breathing in the recovery room Respiratory rate: 10-24 breaths/minute; SpO2 90% or more [with or without supplemental oxygen. Oxygen mask; max. CPAP)]; ability to answer questions and follow commands 9. Pain score of ≤ 4 out of 10 on a numerical rating scale (NRS) of titration to com- fort. In the case of abdominal surgery, pain should be measured 5 minutes after deep breathing and coughing. |
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E.4 | Principal exclusion criteria |
1. Anamnestic allergy or hypersensitivity to: ·fentanyl ·and/or cetylpyridinium HCl ·and/or skin adhesives 2. Suspected or known dependence on strong opioids or a very high need for strong opioids already existing prior to the start of the study 3. Psychological dependence on strong opioids before the start of the clinical study 4. Suspected or known abuse of any drug substance or alcohol 5. Chronic pain disorder 6. Active systemic or active topical skin disease that precludes application of the iontophoretic transdermal system 7. Conditions associated with an increased risk of respiratory depression such as: - Chronic obstructive pulmonary diseases or conditions causing a predisposition for hypoventilation - Head injuries, increased intracranial pressure, brain tumour, impaired consciousness, or coma 8. Post-operative application of CNS active drugs that may increase the risk of re- spiratory depression as a result of additive effects, but excluding: - Anti-depressants/anxiolytics provided they are used for the same therapeutic indication as in the time preceding the operation. - Concomitant medication specified in section 3.3.5. 9. Severe hepatic or renal dysfunction 10. Women who are pregnant, breast feeding, or planning to breast feed within 24 hrs. of the last dose of study drug. Women of childbearing potential must pro- duce a negative pregnancy test prior to admission. This does not apply to women scheduled for a hysterectomy. 11. Participation in a previous clinical trial evaluating the transdermal PCA system, in other clinical studies conducted in parallel and participation in a clinical study within 30 days prior to enrolment in this clinical study 12. Post-operative pain during the first 24 hours that can usually be managed with oral or non-opioid analgesia 13. Employees of the investigator or the institution who had direct involvement in the study or other trials under the direction of the investigator/institution 14. Intra-operative administration of opioids other than morphine, fentanyl, sulfetanil, alfentanil or remifentanil and piritramid as well as up to 50 mg pethidine IV for shivering (only within 30 minutes after arrival in the recovery room) 15. Very high need of opioids for pain control in the postoperative titration phase (> 40 mg morphine iv or > 60 mg piritramide IV or equivalent dose of another strong opioid) 16. Elapse of more than 6 hours since arrival in the recovery room before reaching the pain level ≤ 4 17. Probable Requirement of additional surgical procedures within 72 hours 18. Intubation and use of a laryngeal mask airway at the time of final screening assessments
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E.5 End points |
E.5.1 | Primary end point(s) |
Subject's global assessment at 24 hours |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 25 |
E.8.5 | The trial involves multiple Member States | No |
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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |