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Proton Pump Inhibitor

Nexium for Esophagitis (EE Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Patients must weigh ≥ 10 kg.

Patient's guardian must be capable of giving signed informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 (end of 16-week maintenance phase)

Awards & highlights

EE Trial Summary

This trial will test if Nexium is a safe and effective treatment for young patients with esophagitis.

Who is the study for?

This trial is for children aged 1 to 11 with a history of GERD and confirmed erosive esophagitis (EE). They must have healed EE after an initial treatment phase. Participants need to weigh at least 10 kg, be able to follow contraception guidelines if applicable, and not have severe other diseases or conditions requiring surgery during the study.Check my eligibility

What is being tested?

The study tests whether Nexium at doses of either 10mg or 20mg is effective in keeping erosive esophagitis from coming back in young patients who've already been treated for it. The safety of Nexium will also be monitored throughout the trial.See study design

What are the potential side effects?

Nexium may cause side effects such as headache, diarrhea, nausea, stomach pain, gas, constipation, dry mouth, drowsiness. Serious allergic reactions are rare but possible in those sensitive to PPIs or excipients.

EE Trial Eligibility Criteria

Inclusion Criteria

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

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I weigh at least 10 kilograms.

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My guardian can sign the consent form for me.

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I am between 1 and 11 years old.

EE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 (end of 16-week maintenance phase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 (end of 16-week maintenance phase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 (end of 16-week maintenance phase) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Presence / absence of Erosive Esophagitis

Secondary outcome measures

Percentage of days without rescue medication

Presence/absence of Erosive Esophagitis

EE Trial Design

2Treatment groups

Active Control

Group I: Nexium - Low doseActive Control1 Intervention

Arm 2 (Low dose = ½ healing dose)

Group II: Nexium - high doseActive Control1 Intervention

Arm 1 (High dose = Healing dose)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Little Journey Ltd.UNKNOWN

Laboratory Corporation of AmericaIndustry Sponsor

27 Previous Clinical Trials

9,785 Total Patients Enrolled

AstraZenecaLead Sponsor

4,266 Previous Clinical Trials

288,605,882 Total Patients Enrolled

4 Trials studying Erosive Esophagitis

1,970 Patients Enrolled for Erosive Esophagitis

Media Library

Nexium 10mg (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05267613 — Phase 3

Erosive Esophagitis Research Study Groups: Nexium - Low dose, Nexium - high dose

Erosive Esophagitis Clinical Trial 2023: Nexium 10mg Highlights & Side Effects. Trial Name: NCT05267613 — Phase 3

Nexium 10mg (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267613 — Phase 3

Frequently Asked Questions

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

How can I qualify to participate in this research?

"This clinical trial only accepts participants that have erosive esophagitis and are between 1 and 11 years old. They hope to enroll around 100 individuals in total."

Answered by AI

Are there still vacancies in this research project for new participants?

"The study, which was originally posted on clinicaltrials.gov on 7/1/2022, is still recruiting participants. The most recent update to the posting was on 11/2/2022."

Answered by AI

How many individuals are being allowed to participate in this research project?

"From what is posted on clinicaltrials.gov, it seems as if this study is still looking for volunteers. The listing was first put up on July 1st of this year and was last edited November 2nd. They are in need of one hundred individuals total, recruited from six different locations."

Answered by AI

Does this research involve people who are over 35 years old?

"According to the eligibility requirements listed on this clinical trial, applicants must be aged 1-11 years old. There are 22 trials for patients under 18 and 32 for people over 65."

Answered by AI

In how many distinct places is this trial being overseen?

"Right now, this trial is looking for participants from 6 hospitals. The ones in Carmel, Milwaukee and Miami as well other locations. If you're thinking about enrolling, try to pick a hospital near you so that you won't have to travel much."

Answered by AI

Has the FDA given its okay to sell Nexium in large doses?

"There is some evidence, from Phase 3 trials, to support the efficacy of Nexium - high dose. Furthermore, there is data from multiple rounds of testing that suggest it is a safe medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

2022. "Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05267613.

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