E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ineffective Esophageal Motility |
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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 investigate the acute effect of buspirone hydrochloride (buspar®) administered orally as two 10 mg tablets, on esophageal motility, bolus transit, and symptoms of dysphagia, in patients with IEM. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age >18 and <60 years. 2. Minimum duration of dysphagia history: 2 months. 3. Recent esophago-gastroscopy. 4. A baseline esophageal manometric profile with at least 30% of wet swallows exhibiting any combination of the following abnormalities: (i) non-transmitted contractions (ii) low amplitude contractions (peristaltic contractions with amplitude <30 mmHg in the distal esophagus)1 (iii) a ≥ 2 cm defect in the 30 mm Hg isobaric contour of the distal esophageal segment.19
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E.4 | Principal exclusion criteria |
1. A history of allergic reaction to buspirone, or multiple allergies to several foods and drugs. 2. Pregnancy, lactation. 3. Concomitant administration of monomine oxidase inhibitors (MAOI), verapamil, or diltiazem, or medications affecting esophageal motility . 4. Significant commorbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic). 5. A demonstrable obstructive cause of dysphagia. 6. Prior history of esophageal, ENT or gastric surgery or endoscopic antireflux procedure. 7. A clinical and manometric diagnosis of achalasia, diffuse esophageal spasm, nutcracker esophagus, or hypertensive lower esophageal sphincter (LES).
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Mean pressure wave amplitude at 4, 10 and 16 cm above LES, per swallow type and volume. 2. Mean bolus passage score per swallow type and volume. 3. Percentage of swallows with incomplete bolus transport, per swallow type and volume (impedance).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 trial consists of an accute single dosing of buspar 2 x 10 mg |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |