Title

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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    306
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.
Study Started
Nov 30
2010
Primary Completion
Mar 31
2012
Study Completion
Jun 30
2012
Last Update
Mar 19
2014
Estimate

Drug Eductyl suppository

One suppository every morning during 21 days

Drug Placebo suppository

One suppository every morning during 21 days

Eductyl suppository Experimental

Placebo suppository Placebo Comparator

Criteria

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.
No Results Posted