Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.

Official Title
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Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie

Conditions
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Dyschesia

Intervention / Treatment
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* Drug: Eductyl suppository
* Drug: Placebo suppository


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged from 18 to 75 years old, Writing consent to take part in the study, Patient with a dyschesia according to Rome III criteria An intensity of the inconfort using a VAS (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm Exclusion Criteria: Patient suffering of neurologic affection, Rectal diseases including : Current anal ou peri-anal pain, Current organic injury of colon or rectum, Current anal injury, Current rectal Prolapse, Current haemorrhoid, Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease…), Current ano-recto-colon stenosis (anastomosis, scarring ...) Patient undergone pain killers (WHO level II (except dextropropoxyphen) and III) during the last 8 days, Patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study, Patient with a constipation treatment except if this treatment is regular for at least 15 days 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 15 days (over 5 days in the last 15 days), Patient already included in clinical trial in the last month, Pregnant or breast feeding woman, Woman of childbearing potential without contraception, Patient unable to read and write.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eductyl suppository<br> | Drug: Eductyl suppository<br>* One suppository every morning during 21 days<br>|
| Placebo Comparator: Placebo suppository<br> | Drug: Placebo suppository<br>* One suppository every morning during 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort |  | Day 0 and day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the intensity of inconfort of patients with dyschesia on Likert scale |  | Every day from day 0 to day 21 | 
| To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life |  | Day 0 and day 21 | 
| To assess the efficacy of Eductyl versus placebo on bowel function index |  | Day 0 and day 21 | 
| To assess the efficacy of Eductyl versus placebo on global impression of change |  | Day 21 | 
| To assess the tolerance of Eductyl versus placebo |  | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyschesia treatment, Inconfort related to dyschesia, Quality of life, Bowel function index