Active — Not RecruitingPhase 3

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

United States53 participantsStarted 2022-07-01

Plain-language summary

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

Who can participate

Age range1 Year – 11 Years

SexALL

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Inclusion criteria

✓. Patient must be 1 to 11 years of age
✓. Patients must have a clinical history of GERD for at least 3 months before the start of study
✓. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
✓. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
✓. Patients must weigh ≥ 10 kg.
✓. Patients may be male or female.
✓. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
✓. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention.

Exclusion criteria

✕. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
✕. Significant clinical illness within 4 weeks prior to the start of treatment
✕. 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)
✕. Previous total gastrectomy
✕. Anticipated need for concomitant therapy with PPIs (except for the IMPs), H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in this study
✕. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
✕. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

What they're measuring

Presence / absence of Erosive Esophagitis

Timeframe: Week 24 (end of 16-week maintenance phase)

Trial details

NCT IDNCT05267613

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-14

View on ClinicalTrials.gov More Erosive Esophagitis trials