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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 belowSelect...
I weigh at least 10 kilograms.
Select...
My guardian can sign the consent form for me.
Select...
I am between 1 and 11 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe heart, lung, liver, kidney, blood, or neurological diseases.
Select...
I do not expect to need surgery during the study period.
Select...
I expect to need stomach acid-reducing drugs during the study.
Select...
I have had my entire stomach surgically removed.
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)
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
4,395 Previous Clinical Trials
289,121,517 Total Patients Enrolled
4 Trials studying Erosive Esophagitis
1,970 Patients Enrolled for Erosive Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endoscopy confirmed EE within a week before starting the healing phase.I have not been seriously ill in the last 4 weeks.My esophagus healed after treatment, confirmed by an endoscopy.I weigh at least 10 kilograms.My guardian can sign the consent form for me.I am either male or female.I have had GERD for at least 3 months.I am using or will use effective birth control during the treatment.I do not have severe heart, lung, liver, kidney, blood, or neurological diseases.I do not expect to need surgery during the study period.I have taken a pregnancy test and it is negative.I am between 1 and 11 years old.I expect to need stomach acid-reducing drugs during the study.I have had my entire stomach surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Nexium - Low dose
- Group 2: Nexium - high dose
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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