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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole sodium enteric-coated spheroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300755

3001B3-328

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

1

Active Comparator group

Description:

Arm 1- Low Dose pantoprazole

Treatment:

Drug: pantoprazole sodium enteric-coated spheroid

2

Active Comparator group

Description:

Arm 2- Medium Dose pantoprazole

Treatment:

Drug: pantoprazole sodium enteric-coated spheroid

3

Active Comparator group

Description:

Arm 3- High Dose pantoprazole

Treatment:

Drug: pantoprazole sodium enteric-coated spheroid