The Journal of Pediatrics
Volume 154, Issue 4 , Pages 514-520.e4 , April 2009

Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Assessing the Efficacy and Safety of Proton Pump Inhibitor Lansoprazole in Infants with Symptoms of Gastroesophageal Reflux Disease

  • Susan R. Orenstein, MD

      Affiliations

    • From the University of Pittsburgh School of Medicine, Pittsburgh, PA
    • Corresponding Author InformationCorrespondence to: Susan R. Orenstein, MD, 303 Church Lane, Pittsburgh, PA 15238
    • ,
  • Eric Hassall, MBChB, FRCPC

      Affiliations

    • Division of Gastroenterology, BC Children's Hospital/University of British Columbia, Vancouver, BC, Canada
    • ,
  • Wanda Furmaga-Jablonska, MD, PhD

      Affiliations

    • Department of Neonate and Infant Pathology and Cardiology, Medical University of Lublin, Lublin, Poland
    • ,
  • Stuart Atkinson, MBChB

      Affiliations

    • Takeda Global Research & Development Center, Inc, Deerfield, IL
    • ,
  • Marsha Raanan, MS

      Affiliations

    • Takeda Global Research & Development Center, Inc, Deerfield, IL

Received 2 June 2008 ,Revised 28 July 2008 ,Accepted 30 September 2008.

  • Image Result

    Subject accounting. Shown is the flow of subjects through the study. Compliance for diary completion during screening was ≥ 90% in 94% of randomized subjects. N, number of subjects; DB, double-blind t

    Subject accounting. Shown is the flow of subjects through the study. Compliance for diary completion during screening was ≥ 90% in 94% of randomized subjects. N, number of subjects; DB, double-blind treatment; OL, open-label treatment.

 Takeda Global Research & Development Center, Inc sponsored the clinical trial (ClinicalTrials.gov NCT00324974) and data analysis (TAP Pharmaceutical Products, Inc is now part of Takeda Global Research & Development Center, Inc.). The sponsor provided no financial support for the preparation of this article. S.O., E.H., and W.F.-J. have served as consultants to Takeda Global Research & Development Center, Inc, as well as to other companies making drugs in the same class. S.A. and M.R. are employed by Takeda Global Research & Development Center, Inc.

 No reprints are available from the authors.

PII: S0022-3476(08)00864-0

doi: 10.1016/j.jpeds.2008.09.054

The Journal of Pediatrics
Volume 154, Issue 4 , Pages 514-520.e4 , April 2009

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