A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age

Who is this study for? Pediatric patients 1 to 11 years of age with erosive esophagitis
What treatments are being studied? Nexium
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 11
Healthy Volunteers: f
View:

• 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.

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

Locations
United States
Alabama
Research Site
RECRUITING
Mobile
California
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NOT_YET_RECRUITING
Fontana
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NOT_YET_RECRUITING
Orange
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RECRUITING
Sacramento
Florida
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NOT_YET_RECRUITING
Miami
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RECRUITING
Orlando
Illinois
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NOT_YET_RECRUITING
Downers Grove
Indiana
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RECRUITING
Carmel
Massachusetts
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NOT_YET_RECRUITING
Springfield
New York
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NOT_YET_RECRUITING
The Bronx
Ohio
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RECRUITING
Akron
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RECRUITING
Cleveland
Tennessee
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NOT_YET_RECRUITING
Knoxville
Texas
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NOT_YET_RECRUITING
Dallas
Utah
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NOT_YET_RECRUITING
Salt Lake City
Wisconsin
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RECRUITING
Milwaukee
Other Locations
Argentina
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RECRUITING
Córdoba
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RECRUITING
Córdoba
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RECRUITING
Paraná
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RECRUITING
Rosario
Australia
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RECRUITING
Clayton
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WITHDRAWN
North Adelaide
Belgium
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WITHDRAWN
Brussels
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RECRUITING
Namur
Greece
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RECRUITING
Athens
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Thessaloniki
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RECRUITING
Thessaloniki
Italy
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Messina
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RECRUITING
Napoli
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RECRUITING
Napoli
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RECRUITING
Roma
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RECRUITING
Roma
Lithuania
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WITHDRAWN
Kaunas
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RECRUITING
Vilnius
Portugal
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RECRUITING
Braga
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RECRUITING
Coimbra
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RECRUITING
Lisbon
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RECRUITING
Lisbon
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RECRUITING
Lisbon
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RECRUITING
Porto
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RECRUITING
Porto
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RECRUITING
Viana Do Castelo
Russian Federation
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WITHDRAWN
Novosibirsk
Research Site
WITHDRAWN
Pyatigorsk
Research Site
WITHDRAWN
Saint Petersburg
Research Site
WITHDRAWN
Saint Petersburg
Research Site
WITHDRAWN
Tomsk
Spain
Research Site
RECRUITING
Badalona
Research Site
RECRUITING
Santiago De Compostela
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Seville
Viet Nam
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RECRUITING
Hà Nội
Research Site
RECRUITING
Hanoi
Research Site
RECRUITING
Hanoi
Research Site
RECRUITING
Hochiminh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2027-09-06
Participants
Target number of participants: 50
Treatments
Active_comparator: Nexium - high dose
Arm 1 (High dose = Healing dose)
Active_comparator: Nexium - Low dose
Arm 2 (Low dose = ½ healing dose)
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Medidata Solutions, CISCRP, Calyx, Laboratory Corporation of America, IQVIA RDS Inc., Thermo Fisher Scientific, Inc, Little Journey Ltd., Quipment Inc.

This content was sourced from clinicaltrials.gov