COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes

Takeda1 site in 1 country628 target enrollmentAugust 2006

ConditionsGERD

InterventionsPantoprazole

DrugsPantoprazole

Overview

Phase: Phase 3
Intervention: Pantoprazole
Conditions: GERD
Sponsor: Takeda
Enrollment: 628
Locations: 1
Primary Endpoint: symptom assessment as measured by ReQuest™ questionnaire and investigator.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

April 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
•History of GERD-related symptoms for at least 6 months prior to study inclusion
•Endoscopically confirmed erosive GERD or non-erosive GERD

Exclusion Criteria

•Acute peptic ulcer and/or ulcer complications
•PPIs during last 7 days prior to study start
•Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
•Intake of PPIs in combination with antibiotics for eradication of H. pylori

Arms & Interventions

1

Pantoprazole 40 mg

Intervention: Pantoprazole

Outcomes

Primary Outcomes

symptom assessment as measured by ReQuest™ questionnaire and investigator.

Time Frame: 28 days

Secondary Outcomes

symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator(28 days)
endoscopic healing after 28 days(28 days)
health-related quality of life after 28 days(28 days)
safety.(28 days)