Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

Phase 4

Completed

• Conditions: Dyschesia
• Interventions: Drug: Eductyl suppository; Drug: Placebo suppository

• Registration Number: NCT00910832
• Lead Sponsor: Laboratoires Techni Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eductyl suppository	Eductyl suppository	-
Placebo suppository	Placebo suppository	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms	Day -7, 0, 3, 7, 10, 14, 17, and 21

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation	Day 0 and 21

Trial Locations

Locations (1)

Diaconesses Hospital; 🇫🇷 Paris, France