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Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study.

NCT02113267 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-17

No results posted yet for this study

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 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.

Conditions

  • Eosinophilic Esophagitis

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Mogens Bove

    lead OTHER_GOV

Principal Investigators

  • Mogens Bove, MD,PhD · Dept of ENT, Head&Neck Surgery, NÄL Hospital, Trollhättan, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02113267 on ClinicalTrials.gov