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OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

NCT01642212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-06-08

Study results available
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Summary

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Conditions

  • Eosinophilic Esophagitis (EoE)

Interventions

DRUG

Oral Budesonide Suspension (MB-9)

OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period

DRUG

Placebo

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-23
Primary Completion
2014-10-30
Completion
2014-10-30

Countries

  • United States

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 NCT01642212 on ClinicalTrials.gov