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Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia (EDUCDYS)

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, Inconfort related to dyschesia, Quality of life, Bowel function index

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged from 18 to 75 years old,
  • Writing consent to take part in the study,
  • Patient with a dyschesia according to Rome III criteria
  • An intensity of the inconfort using a VAS (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm

Exclusion Criteria:

  • Patient suffering of neurologic affection,

  • Rectal diseases including :

    • Current anal ou peri-anal pain,
    • Current organic injury of colon or rectum,
    • Current anal injury,
    • Current rectal Prolapse,
    • Current haemorrhoid,
    • Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease…),
    • Current ano-recto-colon stenosis (anastomosis, scarring ...)
  • Patient undergone pain killers (WHO level II (except dextropropoxyphen) and III) during the last 8 days,
  • Patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study,
  • Patient with a constipation treatment except if this treatment is regular for at least 15 days and it won't be modified during the study
  • Intolerance to Eductyl® or to one of its components (potassium tartarate acid, sodium bicarbonate, solid hemisynthethic glycerides, soya lecithin, talc)
  • Use of Eductyl® during the previous 15 days (over 5 days in the last 15 days),
  • Patient already included in clinical trial in the last month,
  • Pregnant or breast feeding woman,
  • Woman of childbearing potential without contraception,
  • Patient unable to read and write.

Sites / Locations

  • Hôpital Foch, Service de Chirurgie Générale et Digestive

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 on VAS of intensity of inconfort

Secondary Outcome Measures

To assess the intensity of inconfort of patients with dyschesia on Likert scale
To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life
To assess the efficacy of Eductyl versus placebo on bowel function index
To assess the efficacy of Eductyl versus placebo on global impression of change
To assess the tolerance of Eductyl versus placebo

Full Information

First Posted
November 17, 2010
Last Updated
March 18, 2014
Sponsor
Laboratoires Techni Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01243723
Brief Title
Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia
Acronym
EDUCDYS
Official Title
Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (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
Yes

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyschesia
Keywords
Dyschesia treatment, Inconfort related to dyschesia, Quality of life, Bowel function index

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
One 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 on VAS of intensity of inconfort
Time Frame
Day 0 and day 21
Secondary Outcome Measure Information:
Title
To assess the intensity of inconfort of patients with dyschesia on Likert scale
Time Frame
Every day from day 0 to day 21
Title
To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life
Time Frame
Day 0 and day 21
Title
To assess the efficacy of Eductyl versus placebo on bowel function index
Time Frame
Day 0 and day 21
Title
To assess the efficacy of Eductyl versus placebo on global impression of change
Time Frame
Day 21
Title
To assess the tolerance of Eductyl versus placebo
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged from 18 to 75 years old, Writing consent to take part in the study, Patient with a dyschesia according to Rome III criteria An intensity of the inconfort using a VAS (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm Exclusion Criteria: Patient suffering of neurologic affection, Rectal diseases including : Current anal ou peri-anal pain, Current organic injury of colon or rectum, Current anal injury, Current rectal Prolapse, Current haemorrhoid, Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease…), Current ano-recto-colon stenosis (anastomosis, scarring ...) Patient undergone pain killers (WHO level II (except dextropropoxyphen) and III) during the last 8 days, Patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study, Patient with a constipation treatment except if this treatment is regular for at least 15 days and it won't be modified during the study Intolerance to Eductyl® or to one of its components (potassium tartarate acid, sodium bicarbonate, solid hemisynthethic glycerides, soya lecithin, talc) Use of Eductyl® during the previous 15 days (over 5 days in the last 15 days), Patient already included in clinical trial in the last month, Pregnant or breast feeding woman, Woman of childbearing potential without contraception, Patient unable to read and write.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Laure Tarrerias, Dr
Organizational Affiliation
Suresnes Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Savarieau, Dr
Organizational Affiliation
Nukleus
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Foch, Service de Chirurgie Générale et Digestive
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia

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