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

Study acronym: EE
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Aug 14, 2026 to Aug 10, 2026
    • Study completion date changed from estimate of Aug 19, 2026 to Aug 10, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Study sites: 42 to 41v30
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 53
    • Study sites: 55 to 42
    • Study completion date: Sep 6, 2027 to Aug 19, 2026
    v29
  4. Re-verified, no change to tracked fieldsv28
  5. Site details revised at 3 of 55 sitesv27
Show 25 earlier versionsHide 25 earlier versions
  1. Enrollment target: 100 to 50
    • Study sites: 53 to 55
    • Study completion date: Nov 6, 2026 to Sep 6, 2027
    v26
  2. Study sites: 52 to 53v25
  3. Re-verified, no change to tracked fieldsv24
  4. Study sites: 45 to 52v23
  5. Site details revised at 3 of 45 sites
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 3 words
    v22
  6. Site details revised at 1 of 45 sitesv21
  7. 6 versions Re-verified since May 23, 2023, no change to tracked fieldsv15-v20
  8. Site details revised at 5 of 45 sitesv14
  9. Re-verified, no change to tracked fieldsv13
  10. Site details revised at 5 of 45 sitesv12
  11. Study sites: 44 to 45v11
  12. Re-verified, no change to tracked fieldsv10
  13. Study description revisedv9
  14. Re-verified, no change to tracked fieldsv8
  15. Study completion date: Sep 3, 2026 to Nov 6, 2026
    • Site details revised at 1 of 44 sites
    v7
  16. Site details revised at 2 of 44 sitesv6
  17. Study completion date: Nov 6, 2026 to Sep 3, 2026
    • Start date changed from estimate of Jun 30, 2022 to Jul 1, 2022
    • Site details revised at 8 of 44 sites
    v5
  18. Start date: May 31, 2022 to Jun 30, 2022
    • Study sites: 41 to 44
    v4
  19. Start date: Apr 29, 2022 to May 31, 2022
    • Site details revised at 1 of 41 sites
    v3
  20. Study sites: 34 to 41v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
729 trials monitored
See 62 trials at risk
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.
Trial Details
NCT Number NCT05267613
Lead Sponsor AstraZeneca
Collaborators: IQVIA RDS Inc., Calyx, Laboratory Corporation of America, Medidata Solutions, Thermo Fisher Scientific, Inc, CISCRP, Quipment Inc., Little Journey Ltd.
Conditions
(from sponsor)		 Erosive Esophagitis
Related terms Gastroesophageal Reflux
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov