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Corticosteroid

Corticosteroids for Esophagogastric Junction Obstruction

Phase < 1

Recruiting

Led By Chanakyaram Reddy, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients age 18 years or older with EGJOO manometric diagnosis based on CC v4.0 criteria

Primary symptom of dysphagia and/or non-cardiac chest pain

Must not have

Contraindication to the use of oral corticosteroids

History of prior foregut surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed upon being on study intervention medication for 14 days

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to investigate if corticosteroid medications can improve the function of the esophageal muscles in patients with a disorder called EGJ outflow obstruction (EGJOO), which causes swallowing

Who is the study for?

This trial is for individuals with EGJOO, a condition where the esophagus muscles don't work well together, causing swallowing difficulties and chest pain. Participants must meet certain criteria not specified here.

What is being tested?

The study tests if corticosteroids can improve esophageal muscle function in EGJOO patients. It involves steroid treatment, measuring muscle movement with esophageal manometry, and completing surveys about symptoms.

What are the potential side effects?

Corticosteroid use may lead to side effects such as increased infection risk, changes in blood sugar levels, mood swings, weight gain, insomnia, and possibly weakening of bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and have been diagnosed with EGJ outflow obstruction.

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I have difficulty swallowing and/or chest pain not related to heart issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take oral corticosteroids due to health reasons.

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I have had surgery on my upper digestive tract.

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I am currently on medication that affects my immune system.

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I have Eosinophilic Esophagitis without control and haven't tried standard treatments.

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I have a hiatal hernia larger than 2 centimeters.

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I have a mass in my esophagus.

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I have a blockage in my esophagus found during an endoscopy.

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I have moderate to severe acid reflux disease.

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I have had a blockage at the junction of my stomach and esophagus.

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I have been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed upon being on study intervention medication for 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed upon being on study intervention medication for 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed upon being on study intervention medication for 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response in esophageal motility to study intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Steroid TreatmentExperimental Treatment3 Interventions

All participants are in the treatment arm. Patients with Esophagogastric Junction Outflow Obstruction (EGJOO) will undergo steroid treatment for 14 days. On the last day of the 14 day treatment, patient will undergo esophageal manometry testing to assess for treatment response. They will also be asked to complete follow-up Eckardt and BEDQ surveys.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Esophageal Manometry

2013

N/A

~40

Steroid treatment

2012

Completed Phase 4

~40