Erosive Esophagitis Clinical Trial
— EEOfficial title:
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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 6, 2026 |
Est. primary completion date | August 14, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 11 Years |
Eligibility | Inclusion Criteria: 1. Patient must be 1 to 11 years of age 2. Patients must have a clinical history of GERD for at least 3 months before the start of study 3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase. 4. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit. 5. Patients must weigh = 10 kg. 6. Patients may be male or female. 7. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment. 8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention. 9. Patient's guardian must be capable of giving signed informed consent Exclusion Criteria: 1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar 2. Significant clinical illness within 4 weeks prior to the start of treatment 3. 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) 4. Previous total gastrectomy 5. 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 6. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment. 7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product 8. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 9. Judgment by the Investigator that the patient should not participate in the study if the patient or guardian is unlikely to comply with study procedures, restrictions, and requirements 10. Previous screening, or enrollment and randomization in the present study |
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | Cordoba | |
Argentina | Research Site | Córdoba | |
Argentina | Research Site | Parana | |
Argentina | Research Site | Rosario | |
Australia | Research Site | Clayton | |
Australia | Research Site | North Adelaide | |
Belgium | Research Site | Namur | |
Greece | Research Site | Athens | |
Greece | Research Site | Thessaloniki | |
Greece | Research Site | Thessaloniki | |
Italy | Research Site | Messina | |
Italy | Research Site | Napoli | |
Italy | Research Site | Napoli | |
Italy | Research Site | Roma | |
Italy | Research Site | Roma | |
Lithuania | Research Site | Kaunas | |
Lithuania | Research Site | Vilnius | |
Portugal | Research Site | Braga | |
Portugal | Research Site | Coimbra | |
Portugal | Research Site | Lisboa | |
Portugal | Research Site | Lisboa | |
Portugal | Research Site | Lisboa | |
Portugal | Research Site | Porto | |
Portugal | Research Site | Porto | |
Portugal | Research Site | Viana do Castelo | |
Russian Federation | Research Site | Novosibirsk | |
Russian Federation | Research Site | Pyatigorsk | |
Russian Federation | Research Site | Saint Petersburg | |
Russian Federation | Research Site | Saint-Petersburg | |
Russian Federation | Research Site | Tomsk | |
Spain | Research Site | Badalona | |
Spain | Research Site | Santiago de Compostela | |
Spain | Research Site | Sevilla | |
Spain | Research Site | Sevilla | |
United States | Research Site | Akron | Ohio |
United States | Research Site | Carmel | Indiana |
United States | Research Site | Cleveland | Ohio |
United States | Research Site | Dallas | Texas |
United States | Research Site | Downers Grove | Illinois |
United States | Research Site | Fontana | California |
United States | Research Site | Knoxville | Tennessee |
United States | Research Site | Miami | Florida |
United States | Research Site | Milwaukee | Wisconsin |
United States | Research Site | Orange | California |
United States | Research Site | Orlando | Florida |
United States | Research Site | Sacramento | California |
United States | Research Site | Salt Lake City | Utah |
United States | Research Site | Springfield | Massachusetts |
Vietnam | Research Site | Ha Noi | |
Vietnam | Research Site | Hanoi | |
Vietnam | Research Site | Hanoi | |
Vietnam | Research Site | Hochiminh |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Calyx, CISCRP (Center for Information and Study on Clinical Research Participation), IQVIA RDS Inc., Laboratory Corporation of America, Little Journey Ltd., Medidata Solutions, Quipment Inc., Thermo Fisher Scientific, Inc |
United States, Vietnam, Argentina, Australia, Belgium, Greece, Italy, Lithuania, Portugal, Russian Federation, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence / absence of Erosive Esophagitis | Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase | Week 24 (end of 16-week maintenance phase) | |
Secondary | Presence/absence of Erosive Esophagitis | Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase | Week 8 (end of healing phase) | |
Secondary | Percentage of days without rescue medication | The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase | Week 8 (end of healing phase) and Week 16 (end of maintenance phase) |
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