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Completed

NCT Number: NCT00910832

Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

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

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Key information

Conditions

Dyschesia Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diaconesses Hospital

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female over 18 years
  • Patients with dyschesia
  • Prescription of rehabilitation for dyschesia

Exclusion criteria

  • Rectal diseases
  • Pain killers
  • Pregnant women
  • Breast feeding patients
  • Non-compliant patients

Treatment and study plan

Eductyl suppository

Drug

one suppository every morning during 21 days

Placebo suppository

Drug

placebo suppository every morning during 21 days

Primary outcomes

  1. To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms

    Time frame: Day -7, 0, 3, 7, 10, 14, 17, and 21

Secondary outcomes

  1. To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation

    Time frame: Day 0 and 21

Sponsors and collaborators

Lead sponsor

Laboratoires Techni Pharma

Industry

Registry information

Official study title

Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation

Acronym: Eductyl

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 1, 2009
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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