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Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

Primary Purpose

Gastroesophageal Reflux

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Pantoprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring GERD, Pantoprazole, NERD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Written informed consent Inpatients (hospitalization during the entire study period is mandatory) Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D) Main Exclusion Criteria: Known Zollinger-Ellison syndrome or other gastric hypersecretory condition Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy) On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm Acute peptic ulcer and/or ulcer complications Pyloric stenosis Known inflammatory bowel diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Pantoprazole 20 mg

Pantoprazole 40 mg

Outcomes

Primary Outcome Measures

Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment

Secondary Outcome Measures

Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment

Symptom relief rates as measured by ReQuest™ after 7 days of treatment

Safety

Full Information

NCT ID

NCT00326027

First Posted

May 15, 2006

Last Updated

May 4, 2012

Sponsor

Nycomed

1. Study Identification

Unique Protocol Identification Number

NCT00326027

Brief Title

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

Official Title

Profi-Study: Symptom Reduction in Hospitalized Patients Suffering From Symptomatic Non-erosive or Erosive Gastroesophageal Reflux Disease Treated With Pantoprazole 20 or 40 mg o.d. for 7 Days

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nycomed

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

Keywords

GERD, Pantoprazole, NERD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Pantoprazole 20 mg

Arm Title

Arm Type

Active Comparator

Arm Description

Pantoprazole 40 mg

Intervention Type

Drug

Intervention Name(s)

Pantoprazole

Intervention Description

Efficacy of Pantoprazole

Primary Outcome Measure Information:

Title

Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment

Time Frame

7 days

Title

Symptom relief rates as measured by ReQuest™ after 7 days of treatment

Time Frame

7 days

Title

Safety

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joachim Mössner, Prof.

Organizational Affiliation

Universitätsklinikum Leipzig, Leipzig, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nycomed Deutschland GmbH

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Brandenburg

ZIP/Postal Code

14770

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Frankfurt

ZIP/Postal Code

60488

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Frankfurt

ZIP/Postal Code

60569

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Greifswald

ZIP/Postal Code

17489

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Halle (Saale)

ZIP/Postal Code

06110

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Hamburg

ZIP/Postal Code

22457

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Ingolstadt

ZIP/Postal Code

85049

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Köln

ZIP/Postal Code

51067

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Köln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Minden

ZIP/Postal Code

32427

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Neubrandenburg

ZIP/Postal Code

17036

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Recklinghausen

ZIP/Postal Code

45655

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Weimar

ZIP/Postal Code

99425

Country

Germany

Facility Name

Nycomed Deutschland GmbH

City

Wiesbaden

ZIP/Postal Code

65189

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

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Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

Gastroesophageal Reflux

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial