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

Last updated: July 8, 2024
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Heartburn (Pediatric)

Heartburn

Esophageal Disorders

Treatment

Nexium 10mg

Nexium 20mg

Clinical Study ID

NCT05267613
D9612C09998
2023-505454-18-00
2020-002515-21
  • Ages 1-11
  • All Genders

Study 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 Criteria

Inclusion

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 startof study

  3. For the healing phase: Patients must have confirmed presence of EE at endoscopyperformed within one week of the start of the healing phase.

  4. For the maintenance phase: Patients must have completed the healing phase and haveendoscopy-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 frominformed consent day up to the last day of study intervention.

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

Exclusion

Exclusion Criteria:

  1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, orneurological 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 (fromthe 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 thisstudy

  6. Participation in another clinical study with an IMP administered in the last 4 weeksbefore enrollment.

  7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of theexcipients of the product

  8. Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).

  9. Judgment by the Investigator that the patient should not participate in the study ifthe patient or guardian is unlikely to comply with study procedures, restrictions,and requirements

  10. Previous screening, or enrollment and randomization in the present study

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Nexium 10mg
Phase: 3
Study Start date:
July 01, 2022
Estimated Completion Date:
November 06, 2026

Study Description

Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age

Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.

Connect with a study center

  • Research Site

    Cordoba, 5000
    Argentina

    Active - Recruiting

  • Research Site

    Córdoba, X5016KEH
    Argentina

    Active - Recruiting

  • Research Site

    Parana, 3100
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, S2000DEJ
    Argentina

    Active - Recruiting

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    North Adelaide, 5006
    Australia

    Active - Recruiting

  • Research Site

    Brussels, 1090
    Belgium

    Active - Recruiting

  • Research Site

    Namur, 5101
    Belgium

    Active - Recruiting

  • Research Site

    Athens, 11527
    Greece

    Active - Recruiting

  • Research Site

    Thessaloniki, 56249
    Greece

    Active - Recruiting

  • Research Site

    Messina, 98125
    Italy

    Active - Recruiting

  • Research Site

    Napoli, 80138
    Italy

    Active - Recruiting

  • Research Site

    Roma, 00161
    Italy

    Active - Recruiting

  • Research Site

    Kaunas, LT50009
    Lithuania

    Active - Recruiting

  • Research Site

    Vilnius, LT-08406
    Lithuania

    Active - Recruiting

  • Research Site

    Braga, 4710
    Portugal

    Active - Recruiting

  • Research Site

    Coimbra, 3000-602
    Portugal

    Active - Recruiting

  • Research Site

    Lisboa, 1169-045
    Portugal

    Active - Recruiting

  • Research Site

    Porto, 4099-001
    Portugal

    Active - Recruiting

  • Research Site

    Viana do Castelo, 4901-858
    Portugal

    Active - Recruiting

  • Research Site

    Novosibirsk, 630007
    Russian Federation

    Suspended

  • Research Site

    Pyatigorsk, 357502
    Russian Federation

    Suspended

  • Research Site

    Saint Petersburg, 196240
    Russian Federation

    Site Not Available

  • Research Site

    Saint-Petersburg, 196158
    Russian Federation

    Suspended

  • Research Site

    Tomsk, 634009
    Russian Federation

    Suspended

  • Research Site

    Badalona, 08916
    Spain

    Active - Recruiting

  • Research Site

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Research Site

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Research Site

    Fontana, California 92335
    United States

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33155
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Research Site

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • Research Site

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Research Site

    Springfield, Massachusetts 01199-1001
    United States

    Site Not Available

  • Research Site

    Akron, Ohio 44308
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Research Site

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75235
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Ha Noi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Hanoi, 10000
    Vietnam

    Active - Recruiting

  • Research Site

    Hochiminh,
    Vietnam

    Active - Recruiting

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