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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014