Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

Takeda1 site in 1 country2,000 target enrollmentMay 2006

ConditionsGastroesophageal Reflux Disease (GERD)

DrugsPantoprazole

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Gastroesophageal Reflux Disease (GERD)
Sponsor: Takeda
Enrollment: 2000
Locations: 1
Primary Endpoint: Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

July 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Takeda

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™

Time Frame: 8 weeks

Secondary Outcomes

Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™(4 and 8 weeks)
Investigator assessment(4 and 8 weeks)
Safety and efficacy(4 and 8 weeks)