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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Techni Pharma

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.