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

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pantoprazole
Placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring GERD, Infants, Gastroesophageal Reflux

Eligibility Criteria

28 Days - 11 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pantoprazole

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients Withdrawn From Study Due to Lack of Efficacy.
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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2006
Last Updated
April 26, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00365300
Brief Title
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
GERD, Infants, Gastroesophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pantoprazole
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Patients Withdrawn From Study Due to Lack of Efficacy.
Description
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.
Time Frame
4 weeks double-blind

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
City
Mays Landing
State/Province
New Jersey
ZIP/Postal Code
08330
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

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

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