Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Techni Pharma
ClinicalTrials.gov Identifier:
NCT00910832
First received: May 29, 2009
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 treated by rectal rehabilitation.


Condition Intervention Phase
Dyschesia
Drug: Eductyl suppository
Drug: Placebo suppository
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 treated by rectal rehabilitation on VAS of intensity of symptoms [ Time Frame: Day -7, 0, 3, 7, 10, 14, 17, and 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 306
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (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
placebo suppository every morning during 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00910832

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

No publications provided by Laboratoires Techni Pharma

Additional 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
Study First Received: May 29, 2009
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
Rehabilitation
Dyschesia

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

ClinicalTrials.gov processed this record on July 24, 2014