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Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
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 Disease focused on measuring GERD, Pantoprazole, Complete Remission

Eligibility Criteria

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

Main Inclusion Criteria: Written informed consent Endoscopically confirmed GERD (Los Angeles classification A-D) Patients whose compliance is expected to be high with respect to the completion of the questionnaires Main Exclusion Criteria: Other gastrointestinal diseases Severe concomitant diseases Proton pump inhibitors (PPIs) during last 14 days before start H2 receptor antagonists, prokinetics during last 7 days before study start Helicobacter pylori (H. pylori) eradication during last 28 days before study start

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

Outcomes

Primary Outcome Measures

time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms

Secondary Outcome Measures

further efficacy criteria
safety

Full Information

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

Unique Protocol Identification Number
NCT00325676
Brief Title
Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)
Official Title
CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (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
The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, 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 Disease
Keywords
GERD, Pantoprazole, Complete Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
639 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Primary Outcome Measure Information:
Title
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
Secondary Outcome Measure Information:
Title
further efficacy criteria
Title
safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Written informed consent Endoscopically confirmed GERD (Los Angeles classification A-D) Patients whose compliance is expected to be high with respect to the completion of the questionnaires Main Exclusion Criteria: Other gastrointestinal diseases Severe concomitant diseases Proton pump inhibitors (PPIs) during last 14 days before start H2 receptor antagonists, prokinetics during last 7 days before study start Helicobacter pylori (H. pylori) eradication during last 28 days before study start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Janssen, MD
Organizational Affiliation
23569 Lübeck, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Belo Horizonte-MG
ZIP/Postal Code
30150270
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Blumenau - SC
ZIP/Postal Code
89010906
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Botucatu - SP
ZIP/Postal Code
18610970
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Campinas - Sao Paulo
ZIP/Postal Code
13070040
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Campinas - SP
ZIP/Postal Code
13013101
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Curitiba - PR
ZIP/Postal Code
80060
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Ilha do Fundao - Rio de Janeiro - RJ
ZIP/Postal Code
21941590
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Pinheiros Sao Paulo - SP
ZIP/Postal Code
1246-000
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Porto Alegre - RS
ZIP/Postal Code
90035003
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Porto Alegre-RS
ZIP/Postal Code
90020090
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Porto Alegre-RS
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Ribeirao Preto-SP
ZIP/Postal Code
14048900
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Salvador-BA
ZIP/Postal Code
41256900
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Sao Paulo
ZIP/Postal Code
4024002
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Bad Schwalbach
ZIP/Postal Code
65307
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Burg
ZIP/Postal Code
39288
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Gardelegen
ZIP/Postal Code
39638
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Königstein
ZIP/Postal Code
61462
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lübeck
ZIP/Postal Code
23569
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lüdenscheid
ZIP/Postal Code
58507
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Lütjenburg
ZIP/Postal Code
24321
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
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wolmirstedt
ZIP/Postal Code
39326
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Inowroclaw
ZIP/Postal Code
88-100
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Poznan
ZIP/Postal Code
60479
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Siemianowice Slaskie
ZIP/Postal Code
41-100
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
Facility Name
Altana Pharma/Nycomed
City
Amanzimtoti
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Berea, Durban
ZIP/Postal Code
4000
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Bloemfontein
ZIP/Postal Code
9317
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Goodwood
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Johannesburg
ZIP/Postal Code
2033
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Overport, Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Panorama
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Pinetown
ZIP/Postal Code
4013
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Pretoria
ZIP/Postal Code
48
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Somerset-West
ZIP/Postal Code
7130
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
24083350
Citation
Monnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Luhmann R, Sander P, Tholen A. Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial. BMC Gastroenterol. 2013 Oct 1;13:145. doi: 10.1186/1471-230X-13-145.
Results Reference
derived

Learn more about this trial

Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

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