Clinical trial NCT01243723: Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia
Official title: Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyschesia
Keywords: Dyschesia treatment
Inconfort related to dyschesia
Quality of life
Bowel function index
Lead sponsor: Laboratoires Techni Pharma
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort
timeFrame: Day 0 and day 21
Secondary outcomes:
measure: To assess the intensity of inconfort of patients with dyschesia on Likert scale
timeFrame: Every day from day 0 to day 21
measure: To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life
timeFrame: Day 0 and day 21
measure: To assess the efficacy of Eductyl versus placebo on bowel function index
timeFrame: Day 0 and day 21
measure: To assess the efficacy of Eductyl versus placebo on global impression of change
timeFrame: Day 21
measure: To assess the tolerance of Eductyl versus placebo
timeFrame: Day 21
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch, Service de Chirurgie Générale et Digestive
Study officials:
affiliation: Suresnes Hospital
name: Anne-Laure Tarrerias, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Nukleus
name: Bernard Savarieau, Dr
role: STUDY_DIRECTOR
References: