E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pruritus secondary to intrathecal opioids |
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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 | 10049981 |
E.1.2 | Term | Drug-induced pruritus |
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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 find the best dose of naloxone that efectively treats drug-induced pruritus, in terms of reduction in pruritus scores and duration of action. |
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E.2.2 | Secondary objectives of the trial |
To assess side effect profile of each dose of naloxone by assessing the effect on duration of analgesia and need for rescue analgesia. Assess effect on nausea and vomiting. Assess pruritus scores between patients who request and those that do not request treatment for pruritus.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Females aged between 18 to 45 years of age who are booked for elective caesarean section delivery. Written consent obtained. |
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E.4 | Principal exclusion criteria |
• Concurrent opioid therapy – prescribed or illicit • Patients in whom spinal anaesthesia is contra-indicated • Allergy to naloxone • Naloxone use within 1 week • Patients that undergo general anaesthesia with no spinal opioid administered • Patients with a past medical history of liver disease eg cholestasis in pregnancy • Patients with a past medical history of kidney disease and a blood creatinine level of over 200 micromol/L. • Patients with severe acute cardiac dysfunction eg unstable angina, MI within the last 3 months, arrythmias or decompensated cardiac failure from medical history • Patients in whom non steroidal anti-inflammatory drugs are contra-indicated • Poor comprehension of assessment tools at the preassessment clinic eg visual analogue pruritus scale (VAPRS).
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E.5 End points |
E.5.1 | Primary end point(s) |
Visual analogue scores for pruritus at 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr and 24 hours post spinal anaesthesia Need for rescue anti-pruritic therapy (in the form of unblinded doses of naloxone)
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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 | No |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
different doses of naloxone |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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The end of the trial will be the last visit of the last subject. We judge this to take place by January 2012. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |