Status:
COMPLETED
Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia
Lead Sponsor:
Laboratoires Techni Pharma
Conditions:
Dyschesia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT01243723
Start Date
November 1 2010
End Date
June 1 2012
Last Update
March 19 2014
Active Locations (1)
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1
Hôpital Foch, Service de Chirurgie Générale et Digestive
Suresnes, France, 92151