Étude comparative, randomisée, double-insu, en groupes parallèles évaluant l’efficacité de l’Eductyl® versus placebo chez des patients présentant des dyschésies traitées par rééducation colo-proctologique
- Conditions
- Patient with dyschesia
- Registration Number
- EUCTR2007-003658-27-FR
- Lead Sponsor
- TECHNI-PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 306
•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:
oregular exoneration difficulties,
ofrequent sensation to have a full rectum,
oregular 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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. ;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. ;Primary end point(s): Change of intensity of symptoms using a VAS between inclusion and final visit
- Secondary Outcome Measures
Name Time Method