Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Overview[ - collapse ][ - ]
Purpose | To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD). |
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Condition | Gastroesophageal Reflux |
Intervention | Drug: pantoprazole Drug: Placebo |
Phase | Phase 3 |
Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
Responsible Party | 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 |
Tracking Information[ + expand ][ + ]
First Received Date | August 16, 2006 |
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Last Updated Date | April 26, 2010 |
Start Date | September 2006 |
Estimated Primary Completion Date | November 2007 |
Current Primary Outcome Measures | Number of Patients Withdrawn From Study Due to Lack of Efficacy.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. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) |
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Official Title | 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. |
Brief Summary | To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Gastroesophageal Reflux |
Intervention | Drug: pantoprazole Drug: Placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 129 |
Estimated Completion Date | November 2007 |
Estimated Primary Completion Date | November 2007 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00365300 |
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Other Study ID Numbers | 3001B3-329 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer |
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer |
Verification Date | April 2010 |
Locations[ + expand ][ + ]
United States, Alabama | Mobile, Alabama, United States, 36604 |
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United States, Arizona | Phoenix, Arizona, United States, 85016 |
United States, Arkansas | Little Rock, Arkansas, United States, 72205 |
United States, California | Oakland, California, United States, 94609 |
United States, California | Orange, California, United States, 92868 |
United States, District of Columbia | Washington, District of Columbia, United States, 20010 |
United States, Florida | Miami, Florida, United States, 33101 |
United States, Florida | Orlando, Florida, United States, 32801 |
United States, Florida | Pensacola, Florida, United States, 32504 |
United States, Florida | Tampa, Florida, United States, 33606 |
United States, Georgia | Augusta, Georgia, United States, 30912 |
United States, Illinois | Peoria, Illinois, United States, 61603 |
United States, Kentucky | Bardstown, Kentucky, United States, 40004 |
United States, Kentucky | Louisville, Kentucky, United States, 40202 |
United States, Massachusetts | Boston, Massachusetts, United States, 02114 |
United States, Michigan | Flint, Michigan, United States, 48503 |
United States, Mississippi | Jackson, Mississippi, United States, 39216 |
United States, Nebraska | Omaha, Nebraska, United States, 68105 |
United States, Nevada | Las Vegas, Nevada, United States, 89109 |
United States, New Jersey | Camden, New Jersey, United States, 08103 |
United States, New Jersey | Mays Landing, New Jersey, United States, 08330 |
United States, New Jersey | Morristown, New Jersey, United States, 07962 |
United States, New York | Brooklyn, New York, United States, 11219 |
United States, New York | Buffalo, New York, United States, 14222 |
United States, New York | Valhalla, New York, United States, 10595 |
United States, North Carolina | Durham, North Carolina, United States, 27710 |
United States, Ohio | Cincinnati, Ohio, United States, 45229 |
United States, Oklahoma | Oklahoma City, Oklahoma, United States, 73104 |
United States, Pennsylvania | Bethlehem, Pennsylvania, United States, 18017 |
United States, Tennessee | Memphis, Tennessee, United States, 38103 |
United States, Texas | Temple, Texas, United States, 76508 |
United States, Utah | Salt Lake City, Utah, United States, 84113 |
United States, Vermont | Burlington, Vermont, United States, 05401 |
United States, Virginia | Norfolk, Virginia, United States, 23507 |
United States, Virginia | Richmond, Virginia, United States, 23219 |
United States, West Virginia | Huntington, West Virginia, United States, 25701 |
United States, West Virginia | Morgantown, West Virginia, United States, 26506 |
United States, Wisconsin | Madison, Wisconsin, United States, 53715 |