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Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00638456
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : September 10, 2009
Sponsor:
Collaborator:
Meritage Pharma, Inc.
Information provided by:
University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 19, 2008
Last Update Posted Date September 10, 2009
Study Start Date  ICMJE February 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
Histologic resolution of esophageal eosinophilia on repeat endoscopy. [ Time Frame: 3 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00638456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • Endoscopic resolution of esophagitis and improvement in EE symptom score as assessed by a pediatric EE questionnaire. [ Time Frame: 3 Months ]
  • Open Label Budesonide given and measured through endoscopic resolution of esophagitis and improvement in EE symptoms [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
Endoscopic resolution of esophagitis and improvement in EE symptom score as assessed by a pediatric EE questionnaire. [ Time Frame: 3 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Official Title  ICMJE Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Brief Summary This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • Drug: Budesonide plus Prevacid
    Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
  • Drug: placebo plus Prevacid
    Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Study Arms  ICMJE
  • Active Comparator: 1
    oral viscous budesonide plus Prevacid
    Intervention: Drug: Budesonide plus Prevacid
  • Placebo Comparator: 2
    placebo plus Prevacid
    Intervention: Drug: placebo plus Prevacid
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2009)
33
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2008)
30
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00638456
Other Study ID Numbers  ICMJE VPI-106-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ranjan Dohil, MD, UCSD
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Meritage Pharma, Inc.
Investigators  ICMJE
Principal Investigator: Ranjan Dohil, MD UCSD
PRS Account University of California, San Diego
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP