Study Evaluating Pantoprazole in Children With GERD

NCT ID: NCT00141817

Last Updated: 2011-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-11-30

Brief Summary

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The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Keywords

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Gastrointestinal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pantoprazole for approximately 9 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Endoscopically proven GERD diagnosed within 6 months before study entry.
* Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria

* History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
* Subjects 6-11 years old unable to swallow tablets
Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Little Rock, Arkansas, United States

Site Status

Orange, California, United States

Site Status

San Diego, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Gainesville, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Pensacola, Florida, United States

Site Status

Park Ridge, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Louisville, Kentucky, United States

Site Status

Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Brockton, Massachusetts, United States

Site Status

Detroit, Michigan, United States

Site Status

Flint, Michigan, United States

Site Status

Jackson, Mississippi, United States

Site Status

Kansas City, Missouri, United States

Site Status

New York, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Memphis, Tennessee, United States

Site Status

Temple, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.

Reference Type DERIVED
PMID: 21740077 (View on PubMed)

Other Identifiers

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B1791059

Identifier Type: -

Identifier Source: secondary_id

3001B3-334

Identifier Type: -

Identifier Source: org_study_id