NCT00910832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

May 29, 2009

Last Update Submit

March 18, 2014

Conditions

Dyschesia

Keywords

Dyschesia treatmentRehabilitationDyschesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Eductyl suppository

EXPERIMENTAL
Drug: Eductyl suppository

Placebo suppository

PLACEBO COMPARATOR
Drug: Placebo suppository

Interventions

Eductyl suppositoryDRUG

one suppository every morning during 21 days

Eductyl suppository
Placebo suppositoryDRUG

placebo suppository every morning during 21 days

Placebo suppository

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over 18 years
  • Patients with dyschesia
  • Prescription of rehabilitation for dyschesia

You may not qualify if:

  • Rectal diseases
  • Pain killers
  • Pregnant women
  • Breast feeding patients
  • Non-compliant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diaconesses Hospital

Paris, 75012, France

Location

Related Publications (1)

  • 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.

    PMID: 24807604DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Odile Cotelle, Dr

    Diaconesses hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 1, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

FR(1)