A Phase 2 interventional study of Mometasone furoate and Placebo in Eosinophilic Esophagitis, sponsored by Mogens Bove. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by Mogens Bove · Phase 2, Interventional, and Treatment
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 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.
322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 215 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →This is the only study on the registry with Mogens Bove as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Drug: Placebo
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.
Also known as: Nasonex
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.
Also known as: Nasonex comparator spray (APL)
Watson Dysphagia Scale Score (WDS)
Difference in WDS score during treatment in active as compared to placebo group.
Time frame: Two months
The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item
Difference in score in active- as compared to placebo- group
Time frame: Two months
"global health and social functioning dimensions" of SF-36
Difference in global health during treatment in active- as compared to placebo group.
Time frame: Two months
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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