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Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

Primary Purpose

Gastroesophageal Reflux

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

About this trial

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

Eligibility Criteria

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

Main Inclusion Criteria: Outpatients Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification Main Exclusion Criteria: Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on >3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start Eradication of H. pylori during the last 28 days prior to study start Acute peptic ulcer and/or ulcer complications

Sites / Locations

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

Primary Outcome Measures

complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.

Secondary Outcome Measures

complete reflux disease remission rates after 4, 8, and 12 weeks
time to reach first complete remission
time to reach sustained complete remission
time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire
average symptom load above pre-defined GERD symptoms threshold
relief rates from reflux disease related complaints after 4, 8 and 12 weeks
endoscopically confirmed healing rates after 4, 8, and 12 weeks
symptom relief rates after 4, 8 and 12 weeks
influence of the H. pylori status on the complete reflux disease remission rate
influence of the H. pylori status on the symptom relief rates
influence of the H. pylori status on the endoscopically confirmed healing rates.

Full Information

First Posted
September 12, 2005
Last Updated
May 4, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00163306
Brief Title
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
Official Title
Complete Remission: Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (GERD) Treated With Pantoprazole 40 Milligram o.d. Over 4 or 8 or 12 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Takeda

4. Oversight

5. Study Description

Brief Summary
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients. When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination). The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. 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
Gastroesophageal Reflux
Keywords
Gastroesophageal Reflux, Gastroesophageal Reflux Disease, 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
1200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Primary Outcome Measure Information:
Title
complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.
Secondary Outcome Measure Information:
Title
complete reflux disease remission rates after 4, 8, and 12 weeks
Title
time to reach first complete remission
Title
time to reach sustained complete remission
Title
time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire
Title
average symptom load above pre-defined GERD symptoms threshold
Title
relief rates from reflux disease related complaints after 4, 8 and 12 weeks
Title
endoscopically confirmed healing rates after 4, 8, and 12 weeks
Title
symptom relief rates after 4, 8 and 12 weeks
Title
influence of the H. pylori status on the complete reflux disease remission rate
Title
influence of the H. pylori status on the symptom relief rates
Title
influence of the H. pylori status on the endoscopically confirmed healing rates.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Outpatients Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification Main Exclusion Criteria: Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on >3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start Eradication of H. pylori during the last 28 days prior to study start Acute peptic ulcer and/or ulcer complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Heinze, MD
Organizational Affiliation
Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com
Official's Role
Study Chair
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Deutschlandsberg
ZIP/Postal Code
8539
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Feldbach
ZIP/Postal Code
8330
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Graz
ZIP/Postal Code
8010
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Krems a. d. Donau
ZIP/Postal Code
3500
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Lilienfeld
ZIP/Postal Code
3180
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
1130
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Wien
ZIP/Postal Code
1170
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
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Bad Schwalbach
ZIP/Postal Code
65307
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Beckum
ZIP/Postal Code
59269
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
Flensburg
ZIP/Postal Code
24937
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Freiburg
ZIP/Postal Code
79098
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
Hamburg
ZIP/Postal Code
22335
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Haßfurt
ZIP/Postal Code
97437
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Herzogenrath
ZIP/Postal Code
52134
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Jülich
ZIP/Postal Code
52428
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Kirchheimbolanden
ZIP/Postal Code
67292
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
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Ludwigshafen
ZIP/Postal Code
67067
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lübeck
ZIP/Postal Code
23569
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lütjenburg
ZIP/Postal Code
24321
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Magdeburg
ZIP/Postal Code
39114
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Magdeburg
ZIP/Postal Code
39130
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
80337
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
München
ZIP/Postal Code
81669
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Nieder-Olm
ZIP/Postal Code
55268
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Oelde
ZIP/Postal Code
59302
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
Rottweil
ZIP/Postal Code
78628
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Saarbrücken
ZIP/Postal Code
66111
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Stuttgart
ZIP/Postal Code
70565
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Tessin
ZIP/Postal Code
18195
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wolfsburg
ZIP/Postal Code
38448
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wolmirstedt
ZIP/Postal Code
39326
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Gyula
ZIP/Postal Code
5700
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
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szombathely
ZIP/Postal Code
9701
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Vác
ZIP/Postal Code
2601
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Drezdenko
ZIP/Postal Code
66-530
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Kielce
ZIP/Postal Code
25-513
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Kraków
ZIP/Postal Code
31-153
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Rzeszow
ZIP/Postal Code
35-068
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Rzeszow
ZIP/Postal Code
35025
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Slupsk
ZIP/Postal Code
76200
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Tychy
ZIP/Postal Code
43-100
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

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