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

Phase 4

Completed

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

• Registration Number: NCT01243723
• 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2012-03
• 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 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.

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 on VAS of intensity of inconfort	Day 0 and day 21

Secondary Outcome Measures

Name	Time	Method
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
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 bowel function index	Day 0 and day 21
To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life	Day 0 and day 21

Trial Locations

Locations (1)

Hôpital Foch, Service de Chirurgie Générale et Digestive; 🇫🇷 Suresnes, France