NCT00638456

Brief Summary

This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
10 years until next milestone

Results Posted

Study results publicly available

August 14, 2019

Completed
Last Updated

August 14, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

March 12, 2008

Results QC Date

July 25, 2019

Last Update Submit

July 25, 2019

Conditions

Eosinophilic Esophagitis

Keywords

EosinophilsEsophagitisMicroscopy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Improvement of Espohageal Eosinophilia

    Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.

    3 Months

Secondary Outcomes (2)

  • Upper Gastrointestinal Endoscopy Score

    Baseline and 3 Months

  • Symptom Score

    Baseline and 3 Months

Study Arms (2)

1

ACTIVE COMPARATOR

oral viscous budesonide plus Prevacid

Drug: Budesonide plus Prevacid

2

PLACEBO COMPARATOR

placebo plus Prevacid

Drug: placebo plus Prevacid

Interventions

Budesonide plus PrevacidDRUG

Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

1
placebo plus PrevacidDRUG

Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.

2

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
  • Ages 1 yrs and older
  • Ability to continue the same diet that the patient was on at the time of EGD with biopsy

You may not qualify if:

  • Adverse reaction or allergy to budesonide
  • Pregnancy
  • Chronic diseases requiring immunomodulatory therapy
  • Use of swallowed topical corticosteroids for EE within the past 3 months
  • Use of systemic steroids 2 months prior to study entry
  • Upper gastrointestinal bleed within 4 months of study entry
  • Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
  • Evidence of adrenal suppression prior to study entry
  • Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
  • Recent changes in asthma or allergic rhinitis therapy for 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rady Children's Hospital, San Diego

San Diego, California, 92123, United States

Location

Related Publications (1)

  • Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.

    PMID: 20457157DERIVED

MeSH Terms

Conditions

Eosinophilic EsophagitisEsophagitis

Interventions

BudesonideLansoprazole

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Ranjan Dohil
Organization
Univeristy of California, San Diego
rdohil@ucsd.edu
(858) 966-4003

Study Officials

  • Ranjan Dohil, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 14, 2019

Results First Posted

August 14, 2019

Record last verified: 2019-07

Locations

US(1)