E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
idiopathic or diabetic gastroparesis
|
Idiopathische of diabetische gastroparese |
|
E.1.1.1 | Medical condition in easily understood language |
stomach cannot empty food in the normal way |
De maag kan voedsel niet afvoeren op de juiste manier. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051153 |
E.1.2 | Term | Diabetic gastroparesis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021227 |
E.1.2 | Term | Idiopathic gastroparesis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 the efficacy of a 12-week treatment with naronapride compared to placebo on disease signs and symptoms in participants with at least moderate idiopathic or diabetic gastroparesis. |
Het evalueren van de effictiviteit van een 12-week durige behandeling met naronapride in vergelijking met een placebo op ziektesymptomen in deelnemers met ten minste matige idiopathische of diabetische gastroparese. |
|
E.2.2 | Secondary objectives of the trial |
To determine the optimal dose-level of naronapride after completion of a 12-week treatment in participants with at least moderate idiopathic or diabetic gastroparesis, To evaluate safety and tolerability of naronapride compared to placebo in participants with at least moderate idiopathic or diabetic gastroparesis |
Het bepalen van de optimale dosis-niveau van naronapride na vervollediging van een 12-weken durende behandeling in deelnemers met ten minste matige idiopathische or diabetische gastroparese. Het Evalueren van veiligheid en tolerantie van Naronapride in vergelijking met placebo in deelnemers met ten minste matige idiopathische of diabetische gastroparese? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men and women between ≥18 and ≤75 years of age -History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 months -Evidence of delayed gastric emptying -Average weekly total symptom score of ≥2.0 - Body Mass Index ≥16 and <35 kg/m2 - Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique
|
- mannen en vrouwen tussen 18 en 75 jaar oud. - Geschiedenis van idiopathische of diabetische gastroparese hoofdsymptomen voor meer dan 3 maanden. - Bewijs van vertraagde maaglediging - gemiddelde wekelijkse totale symptoom score van meer dan 2.0 - Body Mass Index (BMI) tussen 16 en 35 kg/m2 - Exclusie van eender welke mechanische en/of anatomische obstructies, stenose, structurele ziektes, of gastrische ulcers door een gastrointestinale endoscopy/andere beeldvormingstechniek. |
|
E.4 | Principal exclusion criteria |
-Participants without access to an internet-capable terminal and/or without an own e-mail address -History of major gastrointestinal surgery -Intrapyloric botulinum toxin injection within 12 months -Active Gastric stimulator implant -Known secondary causes of gastroparesis -Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis
|
- Deelnemers zonder toegang tot het internet en/of zonder eigen email-adres - geschiedenis van belangrijke gastrointestinale operaties - intrapylorische botulinum toxine injectie binnen de 12 maanden - actief gastrische stimulator implantaat - gekende secondaire oorzaken van gastroparese - aanwezigheid van inflammatoire darmaandoeningen, eosinofiele oesofagitis of reflux oesofagitis, acute gastritis |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6) |
Verandering van de gemiddelde wekelijkse totale symptoom score van baseline (visite 2) tot het einde van de behandeling (visite 6) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
visit 6 (Day 85) |
visite 6 (dag 85) |
|
E.5.2 | Secondary end point(s) |
-Change of the modified and composite average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6) -Change of the average weekly symptom score for nausea/early satiety/postprandial fullness/upper abdominal pain/number of vomiting episodes/bloating from BSL to EOT/WD
|
- verandering van de gemodificeerde en samengestelde gemiddelde wekelijkse totale symptoomscore van baseline (visite 2) tot het einde van de behandeling (visite 6) - verandering van de gemiddelde wekelijkse symptoomscore voor misselijkheid/vroege satiatie/postprandiale volheid/hogere abdominale pijn/aantal braak episodes/opgeblazenheid van baseline to einde van de behandeling |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
visit 6 (Day 85) |
visite 6 (dag 85) |
|
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 | Yes |
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 | Yes |
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 | 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 | 4 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Switzerland |
Australia |
United Kingdom |
United States |
Austria |
Belgium |
France |
Germany |
Italy |
Latvia |
Netherlands |
Poland |
|
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 | 32 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 32 |