Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

NCT ID: NCT00910832

Last Updated: 2014-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Dyschesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eductyl suppository

Group Type EXPERIMENTAL

Eductyl suppository

Intervention Type DRUG

one suppository every morning during 21 days

Placebo suppository

Group Type PLACEBO_COMPARATOR

Placebo suppository

Intervention Type DRUG

placebo suppository every morning during 21 days

Interventions

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Eductyl suppository

one suppository every morning during 21 days

Intervention Type DRUG

Placebo suppository

placebo suppository every morning during 21 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Techni Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Odile Cotelle, Dr

Role: PRINCIPAL_INVESTIGATOR

Diaconesses hospital

Locations

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Diaconesses Hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24807604 (View on PubMed)

Other Identifiers

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EudraCT N° : 2007-0003658-27

Identifier Type: -

Identifier Source: secondary_id

07-EDU-01

Identifier Type: -

Identifier Source: org_study_id

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