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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Techni Pharma
ClinicalTrials.gov Identifier:
NCT01243723
First received: November 17, 2010
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Dyschesia
Drug: Eductyl suppository
Drug: Placebo suppository
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie

Further study details as provided by Laboratoires Techni Pharma:

Primary Outcome Measures:
  • To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort [ Time Frame: Day 0 and day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the intensity of inconfort of patients with dyschesia on Likert scale [ Time Frame: Every day from day 0 to day 21 ] [ Designated as safety issue: No ]
  • To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life [ Time Frame: Day 0 and day 21 ] [ Designated as safety issue: No ]
  • To assess the efficacy of Eductyl versus placebo on bowel function index [ Time Frame: Day 0 and day 21 ] [ Designated as safety issue: No ]
  • To assess the efficacy of Eductyl versus placebo on global impression of change [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • To assess the tolerance of Eductyl versus placebo [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Enrollment: 306
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243723

Locations
France
Hôpital Foch, Service de Chirurgie Générale et Digestive
Suresnes, France, 92151
Sponsors and Collaborators
Laboratoires Techni Pharma
Investigators
Principal Investigator: Anne-Laure Tarrerias, Dr Suresnes Hospital
Study Director: Bernard Savarieau, Dr NuKleus
  More Information

No publications provided

Responsible Party: Laboratoires Techni Pharma
ClinicalTrials.gov Identifier: NCT01243723     History of Changes
Other Study ID Numbers: 2010-021919-17
Study First Received: November 17, 2010
Last Updated: March 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Techni Pharma:
Dyschesia treatment
Inconfort related to dyschesia
Quality of life
Bowel function index

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014