Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia (Eductyl)

March 18, 2014 updated by: Laboratoires Techni Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Diaconesses Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
placebo 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 treated by rectal rehabilitation on VAS of intensity of symptoms
Time Frame: Day -7, 0, 3, 7, 10, 14, 17, and 21
Day -7, 0, 3, 7, 10, 14, 17, and 21

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 0 and 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Techni Pharma

Investigators

  • Principal Investigator: Odile Cotelle, Dr, Diaconesses Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 1, 2009

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-EDU-01
  • EudraCT N° : 2007-0003658-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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