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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2012-005842-39-SE |
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Date of registration:
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05/11/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of patients with eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study
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Scientific title:
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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 |
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Date of first enrolment:
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20/12/2013 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005842-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Mogens Bove
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Address:
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ÖNH-kliniken NÄL
46185
Trollhättan
Sweden |
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Telephone:
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Email:
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mogens.bove@vgregion.se |
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Affiliation:
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Mogens Bove |
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Name:
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Mogens Bove
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Address:
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ÖNH-kliniken NÄL
46185
Trollhättan
Sweden |
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Telephone:
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Email:
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mogens.bove@vgregion.se |
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Affiliation:
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Mogens Bove |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 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
Exclusion criteria:
- 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
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Eosinphilic Esophagitis
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Intervention(s)
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Trade Name: Nasonex
Pharmaceutical Form: Oromucosal spray
Pharmaceutical form of the placebo: Suspension and solution for spray
Route of administration of the placebo: Oromucosal use
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Primary Outcome(s)
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Primary end point(s): Difference in dysphagia total score on Watson Dysphagia Scale (WDS) between value after treatment and at treatment start
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Secondary Objective: Evaluate patients quality of life and any side-effects
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Main Objective: Evaluate the effect of local steroid treatment with Nasonex on swallowing difficulties in patients with eosinophilic esophagitis
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Timepoint(s) of evaluation of this end point: After 8 weeks treatment
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Secondary Outcome(s)
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Secondary end point(s): - Evaluation of EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item
- Evaluation of dysphagia secondary concequences of well being measured in "global health and social functioning dimensions" in SF-36
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Timepoint(s) of evaluation of this end point: After 8 weeks treatment
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Source(s) of Monetary Support
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Västra Götalandsregionen
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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