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Completed

NCT Number: NCT01243723

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Foch, Service de Chirurgie Générale et Digestive

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eductyl suppository

Drug

One suppository every morning during 21 days

Placebo suppository

Drug

One suppository every morning during 21 days

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess the intensity of inconfort of patients with dyschesia on Likert scale

    Time frame: Every day from day 0 to day 21

  2. To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life

    Time frame: Day 0 and day 21

  3. To assess the efficacy of Eductyl versus placebo on bowel function index

    Time frame: Day 0 and day 21

  4. To assess the efficacy of Eductyl versus placebo on global impression of change

    Time frame: Day 21

  5. To assess the tolerance of Eductyl versus placebo

    Time frame: Day 21

Sponsors and collaborators

Lead sponsor

Laboratoires Techni Pharma

Industry

Registry information

Official study title

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

Acronym: EDUCDYS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2010
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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