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Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

Study acronym: STELLAR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jan 1, 2022 to Dec 3, 2026
    • Start date changed from estimate of Jul 1, 2020 to Mar 17, 2023
    • Study sites: 0 to 12
    • Study completion date: Mar 1, 2022 to Dec 3, 2026
    • Secondary endpoints expanded, about 61 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
Trial Details
NCT Number NCT04358146
Lead Sponsor United Pharmaceuticals
Collaborators: Statitec
Conditions
(from sponsor)		 Gastroesophageal Reflux in Children
Related terms Gastroesophageal Reflux
Enrollment 346 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov