Study Evaluating Pantoprazole in Children With GERD

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole for approximately 9 weeks.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141817

B1791059

3001B3-334

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 1 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)