E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Labor pain at the onset of labor in previously healthy women with normal pregnancy |
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E.1.1.1 | Medical condition in easily understood language |
Labor pain at the onset of labor in previously healthy women with normal pregnancy |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059210 |
E.1.2 | Term | Labor pain |
E.1.2 | System Organ Class | 100000004868 |
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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 evaluate the effect of oxycodone on placental and fetal circulation |
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E.2.2 | Secondary objectives of the trial |
The efficacy of oxycodone, concentrations of oxycodone during the study and at birth, the safety of oxycodone to the mother and newborn |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Oxycodone intended to use for labor pain treatment
Age ≥ 18 years
Written informed consent
Full term pregnancy (minimum gestational weeks 37) |
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E.4 | Principal exclusion criteria |
No oxycodone planned to be used
Age less than 18 years
No informed consent
Not full term pregnancy (less than gestational weeks 37)
Allergy to study medicine or the excipients |
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E.5 End points |
E.5.1 | Primary end point(s) |
Placental and fetal circulation during oxycodone administration. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before study drug administration, 30, 60, 120 minutes after study drug administration. |
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E.5.2 | Secondary end point(s) |
The status orf neonate is assessed using Apgar, NACS (Neurologic and Adaptive Capacity Score) and amplitude integrated EEG (aEEG), 24- channel EEG maternal and neonatal concentrations of oxycodone and its metabolites, the efficacy of oxycodone. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The newborn is assessed with Apgar, NACS, aEEG during the first 3 hours after birth. Materal oxycodone concentrations are measured during two hours of Doppler ultrasound assessment, and right after birth. The newborn oxycodone and its metabolite concentrations are measured from umbilical artery and vein after birth when umbilical cord is clamped and cut. The efficacy of oxycodone is assessed during the two hour Doppler ultrasound assessment period. 24-channel EEG is registered during the following day of the birth |
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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 | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
After one hour of the study drug or placebo administration the parturient may request active pain me |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | No |
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 trial is ended when the newborn is assessed using 24 channel EEG registration on the following day of birth. |
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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 |