Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis

NCT ID: NCT00762073

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-08
• Study Completion Date: 2010-04-02

Brief Summary

This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.

Conditions

Eosinophilic Esophagitis (EoE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

oral suspension matching budesonide

2

Low Dose Group

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

oral suspension

3

Medium Dose Group

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

oral suspension

4

High Dose Group

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

oral suspension

Interventions

budesonide

oral suspension

Intervention Type: DRUG

placebo

oral suspension matching budesonide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female subjects between the ages of 2-18 years, inclusive
• History of clinical symptoms of esophageal dysfunction intermittently or continuously
• Histologic evidence of EoE with a peak eosinophil count of greater than or equal to 20 eosinophils per HPF, from two or more levels of the esophagus, within six weeks prior to the Baseline Visit
• At the Baseline Visit, subjects must have symptoms with a total EoE Clinical Symptom Score of greater than or equal to 3
• Willingness and ability to continue the dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression, if any) in effect at the Screening Visit
• Females of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) prior to randomization into the study and sexually active subjects must agree to continue acceptable birth control measures throughout the duration of the study
• Written informed consent (parent or legal guardian) and, as appropriate, subject assent

Exclusion Criteria

• Current use of immunomodulatory therapy (or anticipated use within 12 weeks following the Baseline Visit)
• Diagnosis of inflammatory bowel disease
• Chronic viral infection or immunodeficiency condition (current)
• Use of swallowed topical corticosteroids for EoE in the 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
• Use of systemic (oral or parenteral) corticosteroid within 1 month prior to the biopsy required for entrance to this study or at any time between the biopsy and the Baseline Visit
• Morning plasma cortisol level below the lower limit of normal (per Central Laboratory reference range) at the Screening Visit
• Upper gastrointestinal bleeding within 1 month prior to the Screening Visit or between the Screening Visit and Baseline Visit
• Current use of anticoagulants
• Current disease of the gastrointestinal tract aside from the current EoE diagnosis
• Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
• Evidence of active infection with Helicobacter pylori
• Evidence of unstable asthma or changes in asthma or allergic rhinitis therapy within 1 month prior to the biopsy required for entrance to this study
• Any female who is pregnant, who is planning to become pregnant, or who is breast-feeding
• Current evidence or history of hypersensitivity or idiosyncratic reaction to budesonide or any other ingredients of the study medication
• Current evidence of oropharyngeal or esophageal candidiasis
• Receipt of an investigational drug within 30 days prior to the biopsy required for entrance to this study
• Any condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the subject or successful conduct of the study

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital of Orange County

Orange, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Rady Children's Hospital

San Diego, California, United States

The Children's Hospital

Aurora, Colorado, United States

Emory University-Emory Children's Center

Atlanta, Georgia, United States

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

Children's Memorial Hospital

Chicago, Illinois, United States

Center for Children's Digestive Health

Park Ridge, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Children's Hospital Boston

Boston, Massachusetts, United States

The Center for Human Nutrition

Omaha, Nebraska, United States

Pediatric Gastroenterology and Nutrition Associates

Las Vegas, Nevada, United States

South Jersey Pediatric Gastroenterology

Mays Landing, New Jersey, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Center for Digestive Health

Greenville, South Carolina, United States

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Virginia Commonwealth University, Medical College of Virginia

Richmond, Virginia, United States

Carilion Pediatric Gastroenterology

Roanoke, Virginia, United States

Countries

United States

References

Gupta SK, Hill M, Vitanza JM, Farber RH, Desai NK, Williams J, Song IH. Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis. J Pediatr Gastroenterol Nutr. 2022 Aug 1;75(2):186-191. doi: 10.1097/MPG.0000000000003482. Epub 2022 Jun 6.

Reference Type: DERIVED

PMID: 35666852 (View on PubMed)

Gupta SK, Vitanza JM, Collins MH. Efficacy and safety of oral budesonide suspension in pediatric patients with eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2015 Jan;13(1):66-76.e3. doi: 10.1016/j.cgh.2014.05.021. Epub 2014 Jun 4.

Reference Type: DERIVED

PMID: 24907502 (View on PubMed)

Other Identifiers

MPI-101-01

Identifier Type: -

Identifier Source: org_study_id