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Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00365300
First received: August 16, 2006
Last updated: April 26, 2010
Last verified: April 2010
History of Changes

August 16, 2006
April 26, 2010
September 2006
November 2007   (final data collection date for primary outcome measure)
Number of Patients Withdrawn From Study Due to Lack of Efficacy. [ Time Frame: 4 weeks double-blind ] [ Designated as safety issue: No ]
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.
To assess the efficacy of pantoprazole in infants. The difference in withdrawal rates will be compared between the treatment and placebo groups.
Complete list of historical versions of study NCT00365300 on ClinicalTrials.gov Archive Site
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Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroesophageal Reflux
  • Drug: pantoprazole
  • Drug: Placebo
  • Active Comparator: Pantoprazole
    Intervention: Drug: pantoprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
  • clinical diagnosis of GERD
  • weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

  • known history of upper GI anatomic disorders
  • history of acute life-threatening medical conditions
  • clinically significant medical conditions or laboratory abnormalities
Both
up to 11 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365300
3001B3-329
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP