Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis

NCT01479231 | Withdrawn Phase 1 DMC

• 1 other identifier: 11-003759
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.

Conditions

Gastroesophageal Reflux Disease; Eosinophilic Esophagitis; Dysphagia

Keywords

GERD; Eosinophilic esophagitis; Proton pump inhibitor; dysphagia

Outcome Measures

Primary Outcomes (1)

• Prevalence of Gastroesophageal Reflux Disease

  Prevalence of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis (EoE) Description: The definition of GERD is acid exposure time of \>4.2% over 24 hour period, as measured by pH monitoring.

  24 hour

Secondary Outcomes (4)

• Heartburn/regurgitation

  30 day

• Abnormal 24 hour acid exposure

  24 hour

• Ratio of distal/proximal mean esophageal eosinophil number

  6 weeks

• Mean distal eosinophil number

  6 weeks

Study Arms (1)

dexlansoprazole

EXPERIMENTAL

Drug: dexlansoprazole

Interventions

dexlansoprazole DRUG

Dexlansoprazole 60 mg daily for 6 weeks

Also known as: Dexilant

dexlansoprazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age \< 80 years of age
• eosinophils / hpf on biopsies from esophagus
• Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2"yes", question 4 \> "moderate" and question 7 \> "once a week")
• Clinically performed EGD with \> 14 eosinophils/hpf completed within last 3 months

You may not qualify if:

• Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
• Dilatation of esophagus at time of index endoscopy
• Treatment with topical steroid within 3 months of index endoscopy
• Treatment with PPI in last 30 days prior to index EGD
• Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Eosinophilic Esophagitis; Deglutition Disorders

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jeffrey A Alexander, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 19, 2012

Record last verified: 2012-04