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

Techni-Pharma

Status and phase: Completed; Phase 4

Conditions: Dyschesia

Treatments: Drug: Placebo suppository; Drug: Eductyl suppository

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243723

2010-021919-17

Details and patient eligibility

About

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

Enrollment: 306 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 2 patient groups, including a placebo group

Eductyl suppository

Experimental group

Treatment:

Drug: Eductyl suppository

Placebo suppository

Placebo Comparator group

Treatment:

Drug: Placebo suppository