E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 evaluate the efficacy of EDUCTYL versus PLACEBO for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy on change of symptoms and safety of EDUCTYL versus PLACEBO for treatment of patients with dyschesia treated by rectal rehabilitation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Man or woman aged over 18 years, • Writing consent to take part in the study, • Patient with a prescription of at least 8 rectal rehabilitation sessions, • Patient with a dyschesia confirmed by at least 2 of the following 3 symptoms: o regular exoneration difficulties, o frequent sensation to have a full rectum, o regular absence of sensation to pass a motion. • An intensity of the symptoms using a VAS (0 (no symptom) to 100 mm (maximal imaginable intensity)) equal or over 50 mm
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E.4 | Principal exclusion criteria |
• Patient suffering of neurologic affection, • Rectal diseases including : - Haemorrhoids, - Perineum pain following chirurgical act in this area, - Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease…), - Upper uro-genital prolapse level 2 (Baden-Walker classification), - Rectal Prolapse, - Bulky rectocele, - Haemorrhagic recto colitis - Anal injury, • Patient undergone a rectal treatment, • Patient undergone pain killers (WHO level II and III) during the last 15 days, • Patient undergone anti-depressants except if this treatment is regular for at least 1 month and it won’t be modified during the study, • Patient with a constipation treatment except if this treatment is regular for at least 1 month and it won’t be modified during the study • Intolerance to Eductyl® or to one of its components (potassium tartarate acid, sodium bicarbonate, solid hemisynthethic glycerides, soya lecithin, talc) • Use of Eductyl® during the previous month, • Patient already included in clinical trial in the last 3 months, • Pregnant or breast feeding woman, • Woman of childbearing potential without contraception, • Patient unable to read and write.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change of intensity of symptoms using a VAS between inclusion and final visit |
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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 | No |
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 | 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 | 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.8.3 |
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 | 25 |
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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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 | 16 |
E.8.9.1 | In the Member State concerned days | |