Patient with dyschesia
Conditions
Interventions
Trade Name: EDUCTYL
Product Name: EDUCTYL
Pharmaceutical Form: Suppository
INN or Proposed INN: tartrate acide de potassium
CAS Number: 868-14-4
Concentration unit: g gram(s)
Concentration type: equa
Sponsors
TECHNI-PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Man or woman aged over 18 years, • Writing consent to take part in the study, • Patient with a prescription of at least 8 rectal rehabilitation sessions, • Patient with a dyschesia confirmed by at least 2 of the following 3 symptoms: o regular exoneration difficulties, o frequent sensation to have a full rectum, o regular absence of sensation to pass a motion. • An intensity of the symptoms using a VAS (0 (no symptom) to 100 mm (maximal imaginable intensity)) equal or over 50 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient suffering of neurologic affection, • Rectal diseases including : - Haemorrhoids, - Perineum pain following chirurgical act in this area, - Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease…), - Upper uro-genital prolapse level 2 (Baden-Walker classification), - Rectal Prolapse, - Bulky rectocele, - Haemorrhagic recto colitis - Anal injury, • Patient undergone a rectal treatment, • Patient undergone pain killers (WHO level II and III) during the last 15 days, • Patient undergone anti-depressants except if this treatment is regular for at least 1 month and it won’t be modified during the study, • Patient with a constipation treatment except if this treatment is regular for at least 1 month 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 month, • Patient already included in clinical trial in the last 3 months, • Pregnant or breast feeding woman, • Woman of childbearing potential without contraception, • Patient unable to read and write.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of EDUCTYL versus PLACEBO for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms. ;Secondary Objective: To evaluate the efficacy on change of symptoms and safety of EDUCTYL versus PLACEBO for treatment of patients with dyschesia treated by rectal rehabilitation. ;Primary end point(s): Change of intensity of symptoms using a VAS between inclusion and final visit | — |
Countries
France
Outcome results
None listed