A comparative, randomized, double-blind, parallel-group study evaluating the efficacy of Eductyl® versus placebo in patients with dyschezia treated by colonic-proctological rehabilitation

INTERVENTION: Trade Name: EDUCTYL Product Name: EDUCTYL Pharmaceutical Form: Suppository INN or Proposed INN tartrate acide de potassium CAS Number: 868‐14‐4 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1,150‐ INN or Proposed INN bicarbonate de sodium CAS Number: 144‐55‐8 Concentration unit: g gram(s) Concentration type: equal Concentration number: 0,700‐ Pharmaceutical form of the placebo: Suppository Route of administration of the placebo: Rectal use CONDITION: Patient with dyschesia PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of EDUCTYL versus PLACEBO for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms. Primary end point(s): Change of intensity of symptoms using a VAS between inclusion and final visit Secondary Objective: To evaluate the efficacy on change of symptoms and safety of EDUCTYL versus PLACEBO for treatment of patients with dyschesia treated by rectal rehabilitation. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range