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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
Must not have
Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
Any conditions that are predicted to require a surgery during the study period (from the day of informed consent to the day of the last scheduled visit)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 (end of 16-week maintenance phase)
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart, lung, liver, kidney, blood, or neurological diseases.
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I do not expect to need surgery during the study period.
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I expect to need stomach acid-reducing drugs during the study.
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I have had my entire stomach surgically removed.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence / absence of Erosive Esophagitis
Secondary study objectives
Percentage of days without rescue medication
Presence/absence of Erosive Esophagitis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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)

Find a Location

Who is running the clinical trial?

Little Journey Ltd.UNKNOWN
Laboratory Corporation of AmericaIndustry Sponsor
31 Previous Clinical Trials
18,603 Total Patients Enrolled
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,511 Total Patients Enrolled
4 Trials studying Erosive Esophagitis
1,970 Patients Enrolled for Erosive Esophagitis
IQVIA RDS Inc.UNKNOWN
3 Previous Clinical Trials
14,298 Total Patients Enrolled
CalyxUNKNOWN
1 Previous Clinical Trials
147 Total Patients Enrolled
Quipment Inc.UNKNOWN
Thermo Fisher Scientific, IncIndustry Sponsor
23 Previous Clinical Trials
20,737 Total Patients Enrolled
Medidata SolutionsIndustry Sponsor
23 Previous Clinical Trials
10,450 Total Patients Enrolled
CISCRP (Center for Information and Study on Clinical Research Participation)UNKNOWN

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
~39 spots leftby Aug 2026
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