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

Primary Purpose

GERD

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pantoprazole
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Pantoprazole 40 mg

Outcomes

Primary Outcome Measures

symptom assessment as measured by ReQuest™ questionnaire and investigator.

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2006
Last Updated
May 4, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00336219
Brief Title
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
Official Title
COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Takeda

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
628 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pantoprazole 40 mg
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Intervention Description
Symptom Assessment after treatment with Pantoprozole 40 mg
Primary Outcome Measure Information:
Title
symptom assessment as measured by ReQuest™ questionnaire and investigator.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
Time Frame
28 days
Title
endoscopic healing after 28 days
Time Frame
28 days
Title
health-related quality of life after 28 days
Time Frame
28 days
Title
safety.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Holtmann, Prof.
Organizational Affiliation
Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Bondi Junction
ZIP/Postal Code
NSW 2022
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Box Hill, Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
New South Wales
ZIP/Postal Code
2138
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Altana Pharma/Nycomed
City
Feldbach
ZIP/Postal Code
8330
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Stockerau
ZIP/Postal Code
2000
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Aschersleben
ZIP/Postal Code
6449
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Berlin
ZIP/Postal Code
10409
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Berlin
ZIP/Postal Code
12587
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Berlin
ZIP/Postal Code
13581
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Freising
ZIP/Postal Code
85356
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Germersheim
ZIP/Postal Code
76726
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Grünstadt
ZIP/Postal Code
67269
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Jülich
ZIP/Postal Code
52428
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Köln
ZIP/Postal Code
50999
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Köln
ZIP/Postal Code
51065
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Köthen
ZIP/Postal Code
6366
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Künzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Landsberg
ZIP/Postal Code
6188
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Leipzig
ZIP/Postal Code
4105
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Ludwigshafen
ZIP/Postal Code
67067
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lüneburg
ZIP/Postal Code
21335
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Mönchengladbach
ZIP/Postal Code
41239
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
München
ZIP/Postal Code
80639
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Potsdam-Babelsberg
ZIP/Postal Code
14482
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Saarbrücken
ZIP/Postal Code
66111
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Hatvan
ZIP/Postal Code
3000
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Vác
ZIP/Postal Code
2601
Country
Hungary

12. IPD Sharing Statement

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

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