E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal colic |
Niersteenkolieken |
|
E.1.1.1 | Medical condition in easily understood language |
Renal colic, colic pain |
Niersteenkolieken, koliekpijn |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate whether use of Instanyl® on-demand reduces the pain in patients presenting with an acute renal colic |
Onderzoeken of toedienen van Instanyl® on-demand de pijn bij patiënten met niersteenkolieken reduceert. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate; the duration of pain reduction in patients receiving Instanyl®; the degree of adverse effects in patients receiving Instanyl®. |
- Hoelang zorgt behandeling van niersteenkolieken met Instanyl® voor pijnstilling?
- Welke bijwerkingen treden op bij het toedienen van Instanyl ® in patiënten met acute niersteenkolieken en in welke mate treden deze bijwerkingen op?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: 18 years or older
Renal colic
Opioid naive (previeuous 7 days or less of daily opioid usage)
Informed consent obtained |
18 jaar of ouder
Niersteenkoliek
Opioid-naïef (voorgaande 7 dagen of minder dagelijks gebruik van opioiden)
Informed consent verkregen
|
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E.4 | Principal exclusion criteria |
- Contra-indications for NSAID's or intranasal opioids (Instanyl)
- Opioid tolerant patients
|
- Patiënten met contra-indicaties voor NSAID’s of intranasale
opioiden:
- Opioid tolerante patiënten
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The reduction of pain in mm on a 100 mm VAS-score after 20 minutes
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1. Afname in de pijnbeleving van de patiënt uitgedrukt in afname in mm op de 100 mm VAS-score na 20 minuten
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
T1 = 20 minutes after first administration of Instanyl ® |
T1 = 20 minuten na de eerste toediening van Instanyl ® |
|
E.5.2 | Secondary end point(s) |
2. Adverse events
3. Duration of pain reduction before need for Butylscopolamin IV, |
2. De eventuele bijwerkingen worden nominaal verdeeld en geanalyseerd geanalyseerd. Deze worden door de patiënt vermeld.
3. De periode van effectieve pijnstilling. Dit wordt gezien als de tijd in minuten van T0 tot besloten wordt om aan de deelnemer butylscopolamine intraveneus toe te dienen.
4. 2 weken na inclusie in de studie wordt genoteerd of proefpersonen wel (=1) of niet (=0) alsnog opgenomen zijn voor behandeling met butylscopolamine wegens niersteenkolieken. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. T1 (20 min)
2. When mentioned by the patient.
3. When (in minutes) the decision is made to administer butylscopolamine.
4. 2 weeks after inclusion. |
1. T1 (20 minuten)
2. Wanneer deze door de patiënt wordt vermeld.
3. Wanneer (in minuten) het besluit wordt genomen om butylscopolamine toe te dienen.
4. 2 weken na inclusie. |
|
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |