Status:
TERMINATED
Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study.
Lead Sponsor:
Mogens Bove
Collaborating Sponsors:
Vastra Gotaland Region
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in t...
Eligibility Criteria
Inclusion
- Age over 18 years
- Newly diagnosed cases with diagnostic criteria for EoE (ie at least 15 eosinophils per high power field (Magnification 10 times 40 = x400) in any field of view in any esophageal biopsy and concurrent symptoms of esophageal dysfunction mainly dysphagia.
- Women of childbearing age may participate provided that the pregnancy is not planned , and that contraceptive use during therapy. The investigator will arrange a free pregnancy test must be performed within 1 week before treatment and be negative.
- Participation requires oral and written informed and signed consent form (see patient information and consent forms).
Exclusion
- Local infection of the pharynx or esophagus , such as fungal, bacterial or viral infection
- Active or latent tuberculosis in respiratory tract
- Recent history of major trauma or major surgery
- Recent significant infection or other physical stress
- Signs or suspicion of dehydration
- History of injury, illness or surgery in the adrenals or pituitary
- Pharynx or esophagussurgery or other trauma in the esophagus (incl. foreign body with a sharp object ) where healing has not taken place. (in case of doubt to be assessed by esophago - gastroscopy.
- Planned elective surgery during treatment
- Pregnancy, ongoing or planned
- Women of childbearing potential not using preventives during the study period
- Glaucoma
- Hypersensitivity to any component in the treatments
- Systemic or local steroid treatment last 4 months
- Contraindication to steroid therapy ( immune deficiency or suppression , stomach ulcers, diabetes)
- Medications that affect oesophageal motility (cisapride, erythromycin ) during the treatment period .
- PPIs during or up to 2 weeks before the treatment period
- Other cause of dysphagia (cancer, connective tissue disease , neurological disease )
- Volunteer who can not consent to the study or complete a questionnaire
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02113267
Start Date
April 1 2014
End Date
September 1 2018
Last Update
October 17 2018
Active Locations (1)
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1
ENT dept, NÄL Hospital
Trollhättan, Sweden, SE46185