Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

Phase

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

pantoprazole sodium enteric-coated spheroid

Clinical Study ID

NCT00300755

3001B3-328

Ages 1-5
All Genders

Study Summary

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Ability to undergo endoscopy with required biopsy
Ages 1 through 5 years
Endoscopically confirmed GERD by positive endoscopic evidence of reflux relatedesophagitis or positive histologic evidence of esophagitis consistent with GERD Otherinclusions apply.

Exclusion

Exclusion Criteria:

History or presence of upper gastrointestinal anatomic or motor disorders
Known current or active cow`s milk allergy
Malignancy
Other exclusions apply.

Study Design

pantoprazole sodium enteric-coated spheroid

May 01, 2006

April 30, 2008

Connect with a study center

Edmonton, Alberta T6G 2B7
Canada
Site Not Available
St. John's, Newfoundland and Labrador A1B 3V6
Canada
Site Not Available
Hamilton, Ontario L8N 3Z5
Canada
Site Not Available
London, Ontario N6A 4G5
Canada
Site Not Available
Ottawa, Ontario K1H 8L1
Canada
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Montreal, Quebec H3H 1P3
Canada
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Mobile, Alabama 36604
United States
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Phoenix, Arizona 85016
United States
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Oakland, California 94609
United States
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Orange, California 92868
United States
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Sacramento, California 95819
United States
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San Diego, California 92103
United States
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Wilmington, Delaware 19803
United States
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Washington, District of Columbia 20010
United States
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Gainesville, Florida 32610
United States
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Jacksonville, Florida 32207
United States
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Miami, Florida 33101
United States
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Orlando, Florida 32806
United States
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Pensacola, Florida 32504
United States
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Peoria, Illinois 61603
United States
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Lexington, Kentucky 40536
United States
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Louisville, Kentucky 40202
United States
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Boston, Massachusetts 02115
United States
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Flint, Michigan 48503
United States
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Southfield, Michigan 48075
United States
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Jackson, Mississippi 39216
United States
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Omaha, Nebraska 68105
United States
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Las Vegas, Nevada 89102
United States
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Egg Harbor Township, New Jersey 08234
United States
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Morristown, New Jersey 07962
United States
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Buffalo, New York 14222
United States
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New York, New York 10032
United States
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Oklahoma City, Oklahoma 73104
United States
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Danville, Pennsylvania 17822-1320
United States
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Philadelphia, Pennsylvania 19104
United States
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Houston, Texas 77030
United States
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Temple, Texas 76508
United States
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Norfolk, Virginia 23507
United States
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Charleston, West Virginia 25304
United States
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Huntington, West Virginia 25701-3655
United States
Site Not Available
Milwaukee, Wisconsin 53215
United States
Site Not Available

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