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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00910832
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Dyschesia Drug: Eductyl suppository Drug: Placebo suppository Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation
Study Start Date : May 2009
Primary Completion Date : December 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910832


Locations
France
Diaconesses Hospital
Paris, France, 75012
Sponsors and Collaborators
Laboratoires Techni Pharma
Investigators
Principal Investigator: Odile Cotelle, Dr Diaconesses hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laboratoires Techni Pharma
ClinicalTrials.gov Identifier: NCT00910832     History of Changes
Other Study ID Numbers: 07-EDU-01
EudraCT N° : 2007-0003658-27
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014

Keywords provided by Laboratoires Techni Pharma:
Dyschesia treatment
Rehabilitation
Dyschesia

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