Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Notable Results first posted: May 19, 2010v14 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 65 to confirmed 60
    • Start date: Apr 2006 to May 2006
    • Secondary endpoints: 4 to 3
  3. Minor Trial status: Recruiting to Completed
    • Study sites revised (43)
    v13
  4. Minor Study sites revised (43)v12
  5. Minor Primary and study completion dates: Apr 2008
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study arms: 0 to 3
    • Collaborators expanded, about 1 word
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Study sites: 42 to 43v10
  2. Minor Study sites: 43 to 42
    • Secondary endpoints revised (4)
    v9
  3. Minor Primary endpoint revisedv8
  4. Minor Secondary endpoints revised (4)
    • Primary endpoint revised
    v7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 29 to 43
    • Start date: Aug 2006 to Apr 2006
    v6
  6. Re-verified, no change to tracked fieldsv5
  7. Notable Start date: Apr 2006 to Aug 2006v4
  8. Minor Start date: May 2006 to Apr 2006v3
  9. Minor Start date: Apr 2006 to May 2006v2
  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.
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Trial Details
NCT Number NCT00300755
Lead Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators: Nycomed
Conditions
(from sponsor)
Gastroesophageal Reflux
Related terms Gastroesophageal Reflux
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov