Treatment of eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study for evaluation of treatment effect on group level including symtom questionnaires

-sjukvården, Norra Älvsborgs Länssjukhus0 个研究点目标入组 60 人开始时间: 2013年11月5日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Age >18 years
•- New diagnosed eosinophilic esophagitis according to special criteria
•- Women in fertile age if pregnancy is not planned and contraceptive is used during the treatment period, 8 weeks
•- Verbal and written informed consent
•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 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Local infection in pharynx or esophagus
•- Active or latent tuberculosis in air-route
•- Recent trauma or extensive surgery
•- Recent extensive infection or other physical stress
•- Sign of or suspected dehydration
•- Earlier injury, disease or operation on adrenal gland or hypophysis
•- earlier or clinical signs of adrenal gland insufficience
•- Pharynx- or esophagus surgery or other trauma in esophagus which is not healed
•- Planned elective surgery during treatment period
•- Pregnancy, ongoing or planned
•- Woman in fertile age not using contraceptive during treatment period
•- Glaucoma
•- Hypersensitivity to any of the ingredients
•- General or local steroid treatment during the last 4 months
•- Contra indication to steroid treatment (immune-deficiensy or -suppression, gastric ulcer, diabetes
•- Medication affecting the mobility of the oesophagus during the treatment period
•- Protone pump inhibitor treatment during or up to 2 weeks before treatment period
•- Ulcus ventriculi or duodeni where healing is not verified with endoscopy
•- Other reason for dysphagia ( cancer, connective tissue disorder, neurological disorder)
•- Not able to give consent or completing questionnaires

发起方

-sjukvården, Norra Älvsborgs Länssjukhus