Clinical trial NCT00325676: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Pantoprazole
Complete Remission
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-05-15
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
Secondary outcomes:
measure: further efficacy criteria
measure: safety
Other outcomes:
Locations:
city: Belo Horizonte-MG
country: Brazil
facility: Altana Pharma/Nycomed
city: Blumenau - SC
country: Brazil
facility: Altana Pharma/Nycomed
city: Botucatu - SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Campinas - Sao Paulo
country: Brazil
facility: Altana Pharma/Nycomed
city: Campinas - SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Curitiba - PR
country: Brazil
facility: Altana Pharma/Nycomed
city: Ilha do Fundao - Rio de Janeiro - RJ
country: Brazil
facility: Altana Pharma/Nycomed
city: Pinheiros Sao Paulo - SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Porto Alegre - RS
country: Brazil
facility: Altana Pharma/Nycomed
city: Porto Alegre-RS
country: Brazil
facility: Altana Pharma/Nycomed
city: Porto Alegre-RS
country: Brazil
facility: Altana Pharma/Nycomed
city: Ribeirao Preto-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Salvador-BA
country: Brazil
facility: Altana Pharma/Nycomed
city: Sao Paulo
country: Brazil
facility: Altana Pharma/Nycomed
city: Bad Schwalbach
country: Germany
facility: Altana Pharma/Nycomed
city: Burg
country: Germany
facility: Altana Pharma/Nycomed
city: Gardelegen
country: Germany
facility: Altana Pharma/Nycomed
city: Königstein
country: Germany
facility: Altana Pharma/Nycomed
city: Lübeck
country: Germany
facility: Altana Pharma/Nycomed
city: Lüdenscheid
country: Germany
facility: Altana Pharma/Nycomed
city: Lütjenburg
country: Germany
facility: Altana Pharma/Nycomed
city: Nieder-Olm
country: Germany
facility: Altana Pharma/Nycomed
city: Oelde
country: Germany
facility: Altana Pharma/Nycomed
city: Wiesbaden
country: Germany
facility: Altana Pharma/Nycomed
city: Wolmirstedt
country: Germany
facility: Altana Pharma/Nycomed
city: Bydgoszcz
country: Poland
facility: Altana Pharma/Nycomed
city: Inowroclaw
country: Poland
facility: Altana Pharma/Nycomed
city: Poznan
country: Poland
facility: Altana Pharma/Nycomed
city: Siemianowice Slaskie
country: Poland
facility: Altana Pharma/Nycomed
city: Torun
country: Poland
facility: Altana Pharma/Nycomed
city: Tychy
country: Poland
facility: Altana Pharma/Nycomed
city: Amanzimtoti
country: South Africa
facility: Altana Pharma/Nycomed
city: Berea, Durban
country: South Africa
facility: Altana Pharma/Nycomed
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Durban
country: South Africa
facility: Altana Pharma/Nycomed
city: Goodwood
country: South Africa
facility: Altana Pharma/Nycomed
city: Johannesburg
country: South Africa
facility: Altana Pharma/Nycomed
city: Overport, Durban
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama
country: South Africa
facility: Altana Pharma/Nycomed
city: Pinetown
country: South Africa
facility: Altana Pharma/Nycomed
city: Port Elizabeth
country: South Africa
facility: Altana Pharma/Nycomed
city: Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Somerset-West
country: South Africa
facility: Altana Pharma/Nycomed
Study officials:
affiliation: 23569 Lübeck, Germany
name: Werner Janssen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.