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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)

NCT ID: NCT00325676

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Principal Investigators

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Werner Janssen, MD

Role: PRINCIPAL_INVESTIGATOR

23569 Lübeck, Germany

Locations

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Altana Pharma/Nycomed

Belo Horizonte-MG, , Brazil

Site Status

Altana Pharma/Nycomed

Blumenau - SC, , Brazil

Site Status

Altana Pharma/Nycomed

Botucatu - SP, , Brazil

Site Status

Altana Pharma/Nycomed

Campinas - Sao Paulo, , Brazil

Site Status

Altana Pharma/Nycomed

Campinas - SP, , Brazil

Site Status

Altana Pharma/Nycomed

Curitiba - PR, , Brazil

Site Status

Altana Pharma/Nycomed

Ilha Do Fundao - Rio de Janeiro - RJ, , Brazil

Site Status

Altana Pharma/Nycomed

Pinheiros Sao Paulo - SP, , Brazil

Site Status

Altana Pharma/Nycomed

Porto Alegre - RS, , Brazil

Site Status

Altana Pharma/Nycomed

Porto Alegre-RS, , Brazil

Site Status

Altana Pharma/Nycomed

Porto Alegre-RS, , Brazil

Site Status

Altana Pharma/Nycomed

Ribeirao Preto-SP, , Brazil

Site Status

Altana Pharma/Nycomed

Salvador-BA, , Brazil

Site Status

Altana Pharma/Nycomed

São Paulo, , Brazil

Site Status

Altana Pharma/Nycomed

Bad Schwalbach, , Germany

Site Status

Altana Pharma/Nycomed

Burg, , Germany

Site Status

Altana Pharma/Nycomed

Gardelegen, , Germany

Site Status

Altana Pharma/Nycomed

Königstein, , Germany

Site Status

Altana Pharma/Nycomed

Lübeck, , Germany

Site Status

Altana Pharma/Nycomed

Lüdenscheid, , Germany

Site Status

Altana Pharma/Nycomed

Lütjenburg, , Germany

Site Status

Altana Pharma/Nycomed

Nieder-Olm, , Germany

Site Status

Altana Pharma/Nycomed

Oelde, , Germany

Site Status

Altana Pharma/Nycomed

Wiesbaden, , Germany

Site Status

Altana Pharma/Nycomed

Wolmirstedt, , Germany

Site Status

Altana Pharma/Nycomed

Bydgoszcz, , Poland

Site Status

Altana Pharma/Nycomed

Inowrocław, , Poland

Site Status

Altana Pharma/Nycomed

Poznan, , Poland

Site Status

Altana Pharma/Nycomed

Siemianowice Śląskie, , Poland

Site Status

Altana Pharma/Nycomed

Torun, , Poland

Site Status

Altana Pharma/Nycomed

Tychy, , Poland

Site Status

Altana Pharma/Nycomed

Berea, Durban, , South Africa

Site Status

Altana Pharma/Nycomed

Bloemfontein, , South Africa

Site Status

Altana Pharma/Nycomed

Bloemfontein, , South Africa

Site Status

Altana Pharma/Nycomed

Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Durban, , South Africa

Site Status

Altana Pharma/Nycomed

eManzimtoti, , South Africa

Site Status

Altana Pharma/Nycomed

Goodwood, , South Africa

Site Status

Altana Pharma/Nycomed

Johannesburg, , South Africa

Site Status

Altana Pharma/Nycomed

Overport, Durban, , South Africa

Site Status

Altana Pharma/Nycomed

Panorama, , South Africa

Site Status

Altana Pharma/Nycomed

Pinetown, , South Africa

Site Status

Altana Pharma/Nycomed

Port Elizabeth, , South Africa

Site Status

Altana Pharma/Nycomed

Pretoria, , South Africa

Site Status

Altana Pharma/Nycomed

Somerset West, , South Africa

Site Status

Countries

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Brazil Germany Poland South Africa

References

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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.

Reference Type DERIVED
PMID: 24083350 (View on PubMed)

Other Identifiers

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BY1023/M3-342

Identifier Type: -

Identifier Source: org_study_id

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