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

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

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

Study Overview

• Status: Completed
• Conditions: Dyschesia
• Intervention / Treatment: Drug: Eductyl suppository; Drug: Placebo suppository

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hôpital Foch, Service de Chirurgie Générale et Digestive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eductyl suppository	Drug: Eductyl suppository; One suppository every morning during 21 days
Placebo Comparator: Placebo suppository	Drug: Placebo suppository; One suppository every morning during 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Laboratoires Techni Pharma
• Investigators: Principal Investigator: Anne-Laure Tarrerias, Dr, Suresnes Hospital; Study Director: Bernard Savarieau, Dr, Nukleus

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Quality of life; Dyschesia treatment; Inconfort related to dyschesia; Bowel function index
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2010-021919-17