Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study.
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|ClinicalTrials.gov Identifier: NCT02113267|
Recruitment Status : Terminated (Combination slow recruitment, short shelf life for placebo and insufficient funding for further drug production (probably anyway sufficient number included).)
First Posted : April 14, 2014
Last Update Posted : October 17, 2018
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 the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty and food may be stuck, which typically require acute hospital care with operational action under general anesthesia.( 3,4 ) The standard treatment today is local treatment with steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers, there is only one randomized study which has shown that budesonide has a significant effect exaggerating that of placebo. However, the main end-point in this study was the degree of tissue inflammation.(6) In a separate study using validated questionnaires , we have shown that patients with EoE have distinct organ-specific symptoms and a lowered quality of life . These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that study was not randomized or placebo controlled no causal conclusions could be drawn regarding the treatment effect, but the method of validated questionnaires proved sensitive to changes in symptomatology.(7) Purpose The primary purpose of this study is to evaluate the effect of local steroid treatment with mometasone furoate on swallowing problems in patients with EoE . Secondarily, to evaluate the effect on patient quality of life and the presence of side effects.
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: Mometasone furoate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Experimental: Mometasone furoat
Mometasone furoate monohydrate. 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
Drug: Mometasone furoate
4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
Other Name: Nasonex
Placebo Comparator: Placebo spray
Placebo. 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
Other Name: Nasonex comparator spray (APL)
- Watson Dysphagia Scale Score (WDS) [ Time Frame: Two months ]Difference in WDS score during treatment in active as compared to placebo group.
- The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item [ Time Frame: Two months ]Difference in score in active- as compared to placebo- group
- "global health and social functioning dimensions" of SF-36 [ Time Frame: Two months ]Difference in global health during treatment in active- as compared to placebo group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113267
|ENT dept, NÄL Hospital|
|Trollhättan, Sweden, SE46185|
|Principal Investigator:||Mogens Bove, MD,PhD||Dept of ENT, Head&Neck Surgery, NÄL Hospital, Trollhättan, Sweden|