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

Primary Purpose

Dyschesia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Eductyl suppository
Placebo suppository
Sponsored by
Laboratoires Techni Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyschesia focused on measuring Dyschesia treatment, Rehabilitation, Dyschesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diaconesses Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eductyl suppository

Placebo suppository

Arm Description

Outcomes

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

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

Full Information

First Posted
May 29, 2009
Last Updated
March 18, 2014
Sponsor
Laboratoires Techni Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00910832
Brief Title
Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia
Acronym
Eductyl
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Techni Pharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyschesia
Keywords
Dyschesia treatment, Rehabilitation, Dyschesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eductyl suppository
Arm Type
Experimental
Arm Title
Placebo suppository
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Eductyl suppository
Intervention Description
one suppository every morning during 21 days
Intervention Type
Drug
Intervention Name(s)
Placebo suppository
Intervention Description
placebo suppository every morning during 21 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Cotelle, Dr
Organizational Affiliation
Diaconesses hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diaconesses Hospital
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24807604
Citation
Cotelle O, Cargill G, Marty MM, Bueno L, Cappelletti MC, Colangeli-Hagege H, Savarieau B, Ducrotte P. A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2014 Jun;57(6):781-9. doi: 10.1097/DCR.0000000000000098.
Results Reference
derived

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Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

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