E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with delayed gastric emptying (t1/2 for solids ≥ 109 min) either from idiopathic or diabetic origin |
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E.1.1.1 | Medical condition in easily understood language |
delayed gastric emptying (when it takes ≥ 109 minutes before half of a standard solid meal has left the stomach) either from idiopathic or diabetic origin |
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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 | 14.0 |
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 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 |
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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 investigate the effect of 4-week treatment with Prucalopride on gastric emptying time and meal-related symptoms in idiopathic and diabetic gastroparesis. |
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E.2.2 | Secondary objectives of the trial |
The evaluation of several questionnaires: the PAGI-SYM, PAGI-QoL, the daily symptoms in the patient diary, the Nepean Dyspepsia Index (SF-NDI)symptom scores and the NDI quality of life scores
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Consecutive patients who present to the motility outpatient clinic in whom a diagnosis of diabetic gastroparesis or functional dyspepsia with idiopathic gastroparesis is established according to Rome III criteria, and a diagnosis of delayed gastric emptying is made with a breath test (t1/2 for solids ≥ 109 min)
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E.4 | Principal exclusion criteria |
1. Presence of oesophagitis, gastric atrophy or erosive gastroduodenal lesions on endoscopy
2. Presence of obstructive lesions on small bowel X-ray
3. Major abdominal surgery
4. Underlying psychiatric illness
5. Use of non-steroidal anti-inflammatory drugs, steroids, or drugs affecting gastric motility |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. A decrease in cumulative score for 6 meal-related symptoms (epigastric pain, bloating, postprandial fullness, nausea, belching, and epigastric burning) obtained at each breath sample, using a validated self-administered 4-level Lickert scale
2. A decrease on the PAGI- SYM questionnaire (GCSI) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
week 4 and week 10 of treatment |
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E.5.2 | Secondary end point(s) |
1. A decrease in gastric half emptying time (t1/2) of liquids determined by 13C glycin breath test
2. A decrease in gastric half emptying time (t1/2) of solids determined by 14C octanoic acid breath test
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
week 4 and week 10 of treatment |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 | 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 | 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
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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 | 2 |
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 | 2 |
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 |