Treatment for Esophagitis

1
Effectiveness
2
Safety
Chiara Biaggi de Casenave, MD, Guaynabo, Puerto Rico
Esophagitis
Eligibility
< 18
All Sexes
Eligible conditions
Esophagitis

Study Summary

This study is evaluating whether a lower dose of pantoprazole is as effective as a higher dose of pantoprazole for healing of erosive esophagitis in children.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 3 secondary outcomes in patients with Esophagitis. Measurement will happen over the course of Week 24.

Week 36
Incidence of Adverse Events (AEs)
Number of Participants With Change From Baseline in Laboratory Tests Results
Number of Participants With Change From Baseline in Physical Examinations and Vital Signs
Week 24
Proportion of participants who maintained endoscopically confirmed healing of erosive esophagitis
Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm 1 Full Dose Pantoprazole and matching placebo
Placebo group

This trial requires 110 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 1 Full Dose Pantoprazole and matching placebo
Drug
Full Healing Dose of pantoprazole
Arm 2 Half Dose Pantoprazole and matching placebo
Drug
Half Healing Dose of pantoprazole

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 36 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to 36 weeks for reporting.

Closest Location

Nemours Children's Specialty Care - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
To be in the study, a participant must weigh at least 7 kilograms and be at the 5th percentile for body weight, according to the Centers for Disease Control's standard age and weight chart for the participant's age. show original
I am willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary. show original
The study included male and female participants aged 1 to 17 years. show original
Capable of giving signed informed consent/assent
The participant or parent/legal guardian is willing and able to complete the eDiary. show original
The investigator must discuss the participant's premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of esophagitis?

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Esophagitis is often misdiagnosed as gastroesophageal reflux disease (GERD). Symptoms of GERD include acidic reflux, abdominal pain, and heartburn. On the other hand, symptoms of esophagitis include heartburn, vomiting, hiccups, dry cough and hoarseness, dysphagia, pain and burning sensation in the upper chest and back, and difficulty swallowing. Esophagitis is more common in males.

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What causes esophagitis?

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Esophagitis is uncommon, with a significant number of cases due to reflux esophagitis and peptic oesophagitis. The causes are uncertain. There is a family tendency for reflux esophagitis. Other possible causes include infections, such as histoplasmosis, gastro-oesophageal reflux disease, autoimmune disease, food allergies, drugs and NSAIDS, and anatomical structures such as oesophageal diverticula, oesophageal webs and rings, oesophageal cancer and oesophageal strictures.

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What is esophagitis?

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About 13% of children under the age of 14 in North Europe are affected by esophagitis. It is one of the most common, chronic and reversible gastrointestinal disorders in childhood. esophagitis is a specific disease that develops mainly due to viral and bacterial infection. esophagitis of acute and chronic etiologies usually differs in clinical picture. esophagitis of autoimmune and chronic etiologies usually differs in clinical picture. Esophagitis is one of the common gastrointestinal disorders. Esophagitis affects children and their family, and many times leads to esophageal cancer and other esophageal diseases.

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How many people get esophagitis a year in the United States?

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It is estimated that 14 million Americans have some form of esophagitis a year. Esophagitis causes $13.8 billion a year in direct medical cost in the United States.

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Can esophagitis be cured?

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Esophagitis can be cured by use of esophagoscopy, in addition to standard therapies with the use of medication. Esophagoscopy is an effective way to observe lesions on the esophagus. Esophagoscopy can also be useful for the evaluation of patient prognoses and the monitoring of the progress of treatment.

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What are common treatments for esophagitis?

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Esophagitis is one of the most common causes of peptic ulcer disease. The treatment of esophagitis should follow a stepwise approach starting with aggressive therapy for severe ulcers and then relieving complications by managing pain.

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Have there been other clinical trials involving treatment?

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There is no definitive evidence-based treatment for all patients with esophageal symptoms. Clinicians still need to rely on clinical experience and individual patient factors to treat esophageal symptoms. The authors encourage [patient-physician communications in medical homes for better symptom control and quality of life] for managing and minimizing the esophageal symptoms. Such treatment requires active participation, the collaboration of patients and their HPA caregivers, and professional support for [them as a family members, patients, and providers] in patient care.

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Does esophagitis run in families?

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Esophagitis seems to run in families as indicated by the association of H. pylori positive family history. It is recommended that H. pylori screening be included in the initial assessment of family members in families with a positive family history of esophagitis.

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Who should consider clinical trials for esophagitis?

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Trial participation in patients with dysphagia is more likely if the patient is younger, has reflux, or has previous treatments with reflux, medication, or esophageal motility dysfunction. Patients who have significant symptoms or complications should be evaluated for potential trial participation because they have a greater need.

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How does treatment work?

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In most patients with dysphagia, no treatment was effective and a fundoplication seemed to just get more complicated. Only 12% of our patients benefited and of that group half were cured. In general, the clinical value of all dysphagia treatments is unclear and only few have been adequately studied.

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How serious can esophagitis be?

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Although esophagitis, defined as inflammation of the esophagus, is a common condition with a low risk for cancer, serious complications, including perforation and ulceration are possible if esophagitis is severe. To avoid complications in esophagitis, it is advised to treat esophagitis as soon as possible. In advanced esophageal disease, treatment with an esophageal stenting or a pneumanoesophagostomy (a surgical device passed through the nose and into the esophagus) could potentially be useful treatments.

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What is the latest research for esophagitis?

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It is important for health professionals to know the latest information on esophagitis, which will then help guide management decisions. Clinical scenarios for esophagitis can include Barrett's esophagus (esophagitis with Barrett's metaplasia), erosive esophagitis with a combination of endoscopy and histopathology, and/or erosive esophagitis with concomitant inflammatory bowel disease. Diagnosis can be improved by using HE (Hematoxylin and eosin) stain of endoscopic biopsies, and/or use of endoscopic ultrasonography, manometry, and/or pH monitoring.

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