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

Condition(s) targeted: Gastroesophageal Reflux

Intervention: pantoprazole sodium enteric-coated spheroid (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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

Official title: A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy outcome is the weekly GERD symptom score.

Secondary outcome:

Safety and Tolerability

individual mean frequency of each GERD symptom

individual mean score for respiratory symptoms

change in endoscopy results at end of study in patients with a second endoscopy

Minimum age: 1 Year. Maximum age: 5 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ability to undergo endoscopy with required biopsy

- Ages 1 through 5 years

- Endoscopically confirmed GERD by positive endoscopic evidence of reflux related

esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

Exclusion Criteria:

- History or presence of upper gastrointestinal anatomic or motor disorders

- Known current or active cow` s milk allergy

- Malignancy Other exclusions apply.

Trial Manager, Email: clintrialparticipation@wyeth.com

Mobile, Alabama 36604, United States; Recruiting

Edmonton, Alberta T6G 2B7, Canada; Recruiting

Phoenix, Arizona 85016, United States; Recruiting

San Diego, California 92103, United States; Recruiting

Oakland, California 94609, United States; Recruiting

Sacramento, California 95819, United States; Recruiting

Orange, California 92868, United States; Recruiting

Wilmington, Delaware 19803, United States; Recruiting

Washington, District of Columbia 20010, United States; Recruiting

Pensacola, Florida 32504, United States; Recruiting

Gainesville, Florida 32610, United States; Recruiting

Miami, Florida 33101, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Jacksonville, Florida 32207, United States; Recruiting

Peoria, Illinois 61603, United States; Recruiting

Louisville, Kentucky 40202, United States; Recruiting

Lexington, Kentucky 40536, United States; Recruiting

Boston, Massachusetts 02115, United States; Not yet recruiting

Boston, Massachusetts 02114, United States; Recruiting

Southfield, Michigan 48075, United States; Recruiting

Flint, Michigan 48503, United States; Recruiting

Jackson, Mississippi 39216, United States; Recruiting

Omaha, Nebraska 68105, United States; Recruiting

Las Vegas, Nevada 89102, United States; Recruiting

Egg Harbor Township, New Jersey 08234, United States; Recruiting

Morristown, New Jersey 07962, United States; Recruiting

Buffalo, New York 14222, United States; Recruiting

New York, New York 10032, United States; Recruiting

St. John's, Newfoundland and Labrador A1B 3V6, Canada; Recruiting

Oklahoma City, Oklahoma 73104, United States; Recruiting

London, Ontario N6A 4G5, Canada; Recruiting

Hamilton, Ontario L8N 3Z5, Canada; Recruiting

Ottawa, Ontario K1H 8L1, Canada; Recruiting

Danville, Pennsylvania 17822-1320, United States; Not yet recruiting

Philadelphia, Pennsylvania 19104, United States; Recruiting

Montreal, Quebec H3T 1C5, Canada; Recruiting

Montreal, Quebec H3H 1P3, Canada; Not yet recruiting

Temple, Texas 76508, United States; Completed

Houston, Texas 77030, United States; Recruiting

Norfolk, Virginia 23507, United States; Recruiting

Huntington, West Virginia 25701-3655, United States; Recruiting

Charleston, West Virginia 25304, United States; Recruiting

Milwaukee, Wisconsin 53215, United States; Recruiting

Starting date: April 2006
Ending date: April 2008
Last updated: February 4, 2008