Study Evaluating Pantoprazole in Adolescents With GERD

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Drug: pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367614

3001A3-337

Details and patient eligibility

About

The purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12-16 years old
• clinical diagnosis of GERD
• ability to swallow tablets

Exclusion criteria

• GI or malabsorption disorders
• chronic use of warfarin
• positive pregnancy test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)