E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitamin B12 deficiencies |
Vitamine B12 tekorten |
|
E.1.1.1 | Medical condition in easily understood language |
Vitamin B12 deficiencies |
Vitamine B12 tekorten |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 |
Prospective evaluation of the effect of Vitamin B12 tablets (which are available in stores) in comparison with hydroxocobalamine injections for vitamin B12 deficiencies in patients who underwent a Roux-en-Y Gastric Bypass. |
Prospectieve evaluatie van het effect van vitamine B12 tabletten (die zijn verkrijgbaar in de winkel) in vergelijking met Hydroxocobalamine injecties voor vitamine B12-tekort bij patiënten die een Roux-en-Y Gastric Bypass ondergingen. |
|
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 |
Patients who underwent RYGB
Patients who developed a vitamin B12 deficiency postoperatively |
Patienten die een RYGB ondergingen
Patienten die postoperatief een vitamine B12 tekort hebben ontwikkeld |
|
E.4 | Principal exclusion criteria |
Creatinine> 150 micromol / L
Liver enzymes> 2 times the upper limit
Previous operations on the gastrointestinal tract (except RYGB)
Intercurrerende disease
Gastrointestinal disease
psychiatric illness
known pregnancy |
Kreatinine > 150 micromol/L
Leverenzymen >2 maal de bovengrens
Eerdere operaties aan het maagdarmkanaal (behalve RYGB)
Intercurrerende ziekte
Gastrointestinale ziekte
Psychiatrisch ziektebeeld
Bekende zwangerschap |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Vitamin B12 deficiencies after 1 year |
Vitamine B12 tekorten na 1 jaar. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3, 6 and 12 months after starting of therapy |
3, 6 en 12 maanden na starten van therapie |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 | No |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
observationeel |
observational |
|
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 | 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
|
|
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 | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |