Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

Takeda

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: Pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312806

BY1023/M3-341

Details and patient eligibility

About

The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Written informed consent
• Outpatients of at least 18 years (21 years in Argentina)
• Patient considered to have GERD symptoms

Main Exclusion Criteria:

• Acute peptic ulcer and/or ulcer complications
• Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
• Intake of proton pump inhibitors during the last 10 days before study start
• Female patients of childbearing potential not using adequate means of birth control
• Pregnant or breast-feeding females

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)