E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Changed esophageal sensitivity induced by CRH |
Veranderingen in slokdarmsensitiviteit geïnduceerd door CRH |
|
E.1.1.1 | Medical condition in easily understood language |
Influence of stress on esophageal sensitivity |
Invloed van stress op slokdarmsensitiviteit |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 |
Determine the effect of CRH-administration on esophageal sensitivity in a group of healthy volunteers |
Onderzoeken van het effect van CRH-administratie op de gevoeligheid van de slokdarm in een groep gezonde vrijwilligers |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
niet van toepassing |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy volunteers aged between 18-60 years
No history of gastrointestinal symptoms or complaints. |
Gezonde vrijwilligers, leeftijd 18-60 jaar
Geen voorgeschiedenis van GI symptomen of klachten |
|
E.4 | Principal exclusion criteria |
1. history of allergic reaction to CRH,
2.atopy (eczema, asthma, food allergies, allergic rhinoconjunctivis) or multiple allergies to several drugs,
3. pregnancy or lactation,
4.concomitant administration of monoamine oxidase inhibitors (MAOI), verapamil or diltiazem or medication affecting esophageal motility,
5. significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic),
6. prior history of esophageal, ENT or gastric surgery or endoscopic anti-reflux procedure, history of gastrointestinal disease and first degree relatives with Crohn’s disease or celiac disease.
|
1. Voorgeschiedenis van allergische reacties op CRH
2. Atopy of allergiëen voor andere geneesmiddelen
3. Zwangerschap
4. Inname van geneesmiddelen die de slokdarmmotiliteit en sensitiviteit beïnvloeden
5. Significante comorbiditeiten
6. Voorgeschiedenis van GI-aandoeningen |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine altered esophageal sensitivity after administration of CRH vs placebo |
Nagaan of de slokdarmsensitiveit verandert na toediening van CRH vs placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After administration of CRH or placebo |
Na toediening van CRH of placebo |
|
E.5.2 | Secondary end point(s) |
not applicable |
niet van toepassing |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
unravel the process of symptom perception and visceral sensitivity |
bestuderen van symptoom perceptie en viscerale sensitiviteit |
|
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |