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

Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01243723

Acronym

EDUCDYS

Enrollment

306

Registered

2010-11-18

Start date

2010-11-30

Completion date

2012-06-30

Last updated

2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyschesia

Keywords

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

Brief summary

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

Interventions

DRUGEductyl suppository

One suppository every morning during 21 days

DRUGPlacebo suppository

One suppository every morning during 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia on VAS of intensity of inconfort	Day 0 and day 21

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026