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Trial record 1 of 2 for:    NCT02605837
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A Placebo- Controlled Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved

This study is currently recruiting participants.
Verified November 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT02605837
First Posted: November 16, 2015
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.

Condition Intervention Phase
Eosinophilic Esophagitis (EoE) Drug: OBS Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Histologic response, defined as a peak eosinophil count of ≤6/HPF across all available esophageal levels at the final evaluation after 16 weeks of treatment [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]
  • Dysphagia symptom response, defined as ≥30% reduction in the Dysphagia Symptom Questionnaire (DSQ) combined score (questions 2+3) [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]

Secondary Outcome Measures:
  • Reduction in dysphagia symptoms, as measured by the DSQ combined score (binary response criteria and change) [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]
  • Response of endoscopically identified esophageal features using the EoE Endoscopic Reference Score (EREFS) [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]
  • Peak eosinophil count (binary response criteria and change) [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]
  • Impact on pain as measured by pain with swallowing on DSQ [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]
  • Impact on symptoms as measured by combined DSQ rating of dysphagia and pain with swallowing [ Time Frame: From baseline to the end of the treatment period (visit at 16 weeks of treatment) ]
  • Number of participants with adverse events by MedDRA preferred term as a measure of safety and tolerability [ Time Frame: course of therapy (16 weeks) ]
  • Pharmakokinetic data in adult subjects will be determined from the plasma concentration-time data for budesonide by non-compartmental analysis. [ Time Frame: From baseline to the end of the treatment period, (visit at 16 weeks of treatment) ]
  • Area under the curve (AUC0-tau) for the plasma concentration-time data for budesonide by non-compartmental analysis. [ Time Frame: From baseline to the end of the treatment period, (visit at 16 weeks of treatment) ]
  • Maximum concentration (Cmax) occurring at tmax for plasma concentration for budesonide by non-compartmental analysis. [ Time Frame: From baseline to the end of the treatment period, (visit at 16 weeks of treatment) ]
  • Time of maximum (tmax) for the observed concentration for budesonide by non-compartmental analysis. [ Time Frame: From baseline to the end of the treatment period, (visit at 16 weeks of treatment) ]
  • Response of histopathologic epithelial features combined total score by central reviewer grading and staging compared to placebo as measured by the EREFS [ Time Frame: Screening to week 16 ]

Estimated Enrollment: 300
Study Start Date: November 1, 2015
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OBS
Oral Bedesonide Suspension
Drug: OBS
Oral Budesonide Suspension 10 mL of 0.2 mg/mL every morning and at bedtime
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Identical presentation of the experimental drug administered orallys as specified

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Planned duration of screening period: 3-6 weeks, planned duration of treatment period: 16 weeks, planned duration of safety follow-up period: 4 weeks
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02605837


Contacts
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

  Show 70 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Ikuo Hirano, MD Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02605837     History of Changes
Other Study ID Numbers: SHP621-301
First Submitted: November 4, 2015
First Posted: November 16, 2015
Last Update Posted: November 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists