Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

Phase 3

Completed

• Conditions: GERD
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00336219
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-12
• Study First Submitted QC: 2006-06-12
• Study First Posted: 2006-06-13
• Study Start: 2006-08
• Primary Completion: 2006-11
• Study Completion: 2007-04
• Status Verified: 2008-10
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 628

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

Main

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pantoprazole	Pantoprazole 40 mg

Primary Outcome Measures

Name	Time	Method
symptom assessment as measured by ReQuest™ questionnaire and investigator.	28 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Altana Pharma/Nycomed; 🇭🇺 Vác, Hungary