E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperativ smertebehandling efter laparoskopisk kolon kirurgi hos patienter med colon cancer
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | Colon cancer |
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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 |
Primære effektmål
• Smertescore (VAS hoste 6 timer postoperativt) |
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E.2.2 | Secondary objectives of the trial |
Sekundære effektmål
• Det totale morfinbehov 0-24 timer postoperativt. • Smertescore i hvile (AUC/24 t) (baseret på smertemålinger 2,4,6,12,18 og 24 timer postoperativt). • Smertescore ved hoste (AUC/24 t) (baseret på smertemålinger 2,4,6,12,18 og 24 timer postoperativt). • Graden af kvalme og antal af opkastninger 2,4,6,12,18 og 24 timer postoperativt.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inklusionskriterier. Patienterne skal opfylde alle følgende kriterier for at være egnede til inklusion i undersøgelsen: • Alder >18 år og <80 år • Patienter indstillet til laparoskopisk kirurgi på kolon, på baggrund af cancer. • Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud. • ASA 1-3. • BMI > 18 og < 40
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E.4 | Principal exclusion criteria |
Eksklusionskriterier. Patienter, der opfylder et eller flere af følgende kriterier, er ikke egnede til inklusion i denne undersøgelse: • Patienter som ikke kan samarbejde til undersøgelsen. • Patienter som ikke forstår eller taler dansk. • Allergi over for de i undersøgelsen anvendte stoffer. • Konvertering til åben kirurgi • Har diagnoserne Morbus Chron eller Colitis Ulcerosa • Graviditet, undersøgt med HCG-blodprøve på operationsdagen. • Alkohol- og/eller medicinmisbrug – efter investigators skøn. • Kronisk smerte med daglig indtagelse af opioid præparater. • Infektion ved indstiksområdet.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primære effektmål • Smertescore ved hoste (baseret på smertemålinger 2,4,6,12,18 og 24 timer postoperativt).
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
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 | 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 | Yes |
E.8.2.3 | Other | No |
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 | 80 |
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 | Yes |
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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Studiet ender når 80 personer er inkluderet i studiet. Dette fremgår tillige af forsøgsprotokollen. |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |