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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00336219

Enrollment

628

Registered

2006-06-13

Start date

2006-08-31

Completion date

2007-04-30

Last updated

2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

GERD, Pantoprazole

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.

Interventions

DRUGPantoprazole

Symptom Assessment after treatment with Pantoprozole 40 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main 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

Design outcomes

Primary

Measure	Time frame
symptom assessment as measured by ReQuest™ questionnaire and investigator.	28 days

Secondary

Measure	Time frame
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

Countries

Australia, Austria, Germany, Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026