Étude comparative, randomisée, double-insu, en groupes parallèles évaluant l’efficacité de l’Eductyl® versus placebo chez des patients présentant des dyschésies traitées par rééducation colo-proctologique

TECHNI-PHARMA0 个研究点目标入组 306 人开始时间: 2007年7月23日最近更新: 2012年3月19日

试验速览

暂无简介。

•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:
•oregular exoneration difficulties,
•ofrequent sensation to have a full rectum,
•oregular 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

•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.

发起方

TECHNI-PHARMA