E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Functional abdominal pain |
Functionele buikpijn |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic abdominal pain without somatic cause |
Chronische buikpijn waarvoor geen lichamelijke oorzaak gevonden is |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 establish the effectiveness of laxative therapy in children with functional abdominal pain |
Vaststellen van het effect van laxeren bij kinderen met functionele buikpijn |
|
E.2.2 | Secondary objectives of the trial |
To establish if laxative therapy is effective in all functional abdominal pain syndromes, according to the Rome criteria, including functional dyspepsia and the diarrhea variant of irritable bowel syndrome |
Vaststellen van het effect van laxeren bij de verschillende functionele buikpijnsyndromen (Rome criteria), inclusief functionele dyspepsie en de diarree variant van het prikkelbare darmsyndroom |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. age 4-18 years; and 2. fulfilling the Rome IV criteria for functional abdominal pain disorders, with exception of the criterion for IBS-patients that the pain does not resolve with resolution of the constipation.
|
1. leeftijd 4-18 jaar; en 2.voldoen aan de criteria voor functionele buikpijn (Rome IV criteria), met uitzondering van het criterium voor patiënten met het prikkelbare darmsyndroom dat de pijn niet verdwijnt bij verdwijnen van de obstipatie |
|
E.4 | Principal exclusion criteria |
1. insufficient knowledge of the Dutch language; 2. earlier therapy with generic macrogol; 3. participation of a sibling in the study; 4. abdominal pain less than 2x per week in the diagnostic phase according to diary. 5. diagnosis ‘functional constipation’ (Rome IV criteria)
|
1. onvoldoende beheersing van de Nederlandse taal; 2. eerdere behandeling met generiek macrogol; 3. deelname van een broer of zus aan de studie; 4. buikpijn minder dan 2x per week in de diagnostische fase (dagboek); 5. diagnose ‘functionele obstipatie’ volgens de Rome IV criteria.
|
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients being pain free by laxative measures |
Percentage patiënten dat pijnvrij is met laxerende maatregelen |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 4 weeks of therapy and at follow up 6 months later |
Na 4 weken therapie en bij follow up 6 maanden later |
|
E.5.2 | Secondary end point(s) |
Percentage decrease of pain score by laxative measures |
Percentage vermindering van de pijnscore met laxerende maatregelen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 4 weeks of therapy and at follow up 6 months later |
Na 4 weken therapie en bij follow up 6 maanden later |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Pathophysiology: to establish if the effect of laxative measures differs between the different functional abdominal pain syndromes, according to the Rome criteria |
Pathofysiologie: vaststellen of het effect van laxerende maatregelen verschillend is bij de verschillende functionele buikpijnsyndromen volgens de Rome criteria |
|
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 | 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 | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | 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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |