E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Medical and post surgical ICU patient requiring analgesia and sedation. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039897 |
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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 |
To quantify the difference in time on the mechanical ventilator when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. |
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E.2.2 | Secondary objectives of the trial |
-To assess the difference in length of stay in ICU when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. -To demonstrate significant reductions in the use of concomitant sedative agents/opioid e.g. propofol when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. -To quantify the difference in time taken to extubate a subject when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Age 18 years or more 2.Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation. 3.Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug. 4.Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid. 5.Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control that must be recorded on the source documentation at each visit; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows a.Non-childbearing potential i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses b.Child-bearing potential, has a negative serum pregnancy test result at the Screening Visit and negative urine dipstick pregnancy tests before starting study medication and on the other occasions, and agrees to one of the following -Male partner who is sterile prior to the female subject s entry into the study and is the sole sexual partner for that female subject -Oral contraceptives either combined or progestogen only with barrier method of contraception consisting of condom or diaphragm before and throughout the clinical trial, and for one month following the last dose of study medication. Women of child-bearing potential using an oral contraceptive in combination with a barrier method of contraception are required to continue to use this form of contraception for one month following discontinuation of study medication. -Barrier method of contraception consisting of condom or diaphragm -IUD with a documented failure rate of less than 1 per year -Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug minimum for one month, equivalent to five half lives . -the subjects will remain abstinent during the period described above, but they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active. 6.Subjects provided written informed consent for the study. |
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E.4 | Principal exclusion criteria |
1.Diagnosis resuscitation in the previous 24 hours, all traumatisms or expecting to require major surgery within the next three days 2.Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided 3.Concurrent medications -Requires or is likely to require neuromuscular blocking agents to facilitate mechanical ventilation -Has or is likely to receive an epidural block during the treatment period 4.The use of remifentanil or propofol is contraindicated 5.Drug allergy history of allergic hypersensitivity to fentanyl analogues, morphine, benzodiazepines or propofol 6.History of alcohol abuse 7.History of drug abuse, defined as -Patterns of substance intake consistent with disruption of normal function in society -Past or current impairment of organ function reasonably related to substance intake 8.Previous entry into this study or participation in any other investigational drug study within 30 days of study entry 9.Currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device 10.Protocol specified treatment regimens would be inappropriate for the management of the subject. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of time on mechanical ventilation reducing the duration of mechanical ventilation may reduce the length of stay and therefore reduce the costs per patient. Due to its unique profile, remifentanil may help to reduce the duration of mechanical ventilation . |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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.8.5 | 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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |