Clinical trial NCT00312806: Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Official title: Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease
GERD
Pantoprazole
ReQuestTM
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-04-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent
* Outpatients of at least 18 years (21 years in Argentina)
* Patient considered to have GERD symptoms

Main Exclusion Criteria:

* Acute peptic ulcer and/or ulcer complications
* Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (\> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
* Intake of proton pump inhibitors during the last 10 days before study start
* Female patients of childbearing potential not using adequate means of birth control
* Pregnant or breast-feeding females

Primary outcomes:
measure: Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
timeFrame: 8 weeks
Secondary outcomes:
measure: Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
timeFrame: 4 and 8 weeks
measure: Investigator assessment
timeFrame: 4 and 8 weeks
measure: Safety and efficacy
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Altana Pharma/Nycomed
city: Buenos Aires
country: Argentina
facility: Altana Pharma/Nycomed
city: Buenos Aires
country: Argentina
facility: Altana Pharma/Nycomed
city: La Plata
country: Argentina
facility: Altana Pharma/Nycomed
city: Bedford Park SA
country: Australia
facility: Altana Pharma/Nycomed
city: Bondi Junction
country: Australia
facility: Altana Pharma/Nycomed
city: Fitzroy
country: Australia
facility: Altana Pharma/Nycomed
city: Footscray
country: Australia
facility: Altana Pharma/Nycomed
city: Fremantle, WA
country: Australia
facility: Altana Pharma/Nycomed
city: Kippa_ring
country: Australia
facility: Altana Pharma/Nycomed
city: Melbourne
country: Australia
facility: Altana Pharma/Nycomed
city: NSW
country: Australia
facility: Altana Pharma/Nycomed
city: Penrith, NSW
country: Australia
facility: Altana Pharma/Nycomed
city: Phrahran
country: Australia
facility: Altana Pharma/Nycomed
city: Deutschlandsberg
country: Austria
facility: Altana Pharma/Nycomed
city: Feldbach
country: Austria
facility: Altana Pharma/Nycomed
city: Graz
country: Austria
facility: Altana Pharma/Nycomed
city: Krems a. d. Donau
country: Austria
facility: Altana Pharma/Nycomed
city: Lilienfeld
country: Austria
facility: Altana Pharma/Nycomed
city: St. Pölten
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Bouge
country: Belgium
facility: Altana Pharma/Nycomed
city: Brussels
country: Belgium
facility: Altana Pharma/Nycomed
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed
city: Edegem
country: Belgium
facility: Altana Pharma/Nycomed
city: Eupen
country: Belgium
facility: Altana Pharma/Nycomed
city: Gent
country: Belgium
facility: Altana Pharma/Nycomed
city: Jette
country: Belgium
facility: Altana Pharma/Nycomed
city: Kortrijk
country: Belgium
facility: Altana Pharma/Nycomed
city: Leuven
country: Belgium
facility: Altana Pharma/Nycomed
city: Merksem
country: Belgium
facility: Altana Pharma/Nycomed
city: Oostende
country: Belgium
facility: Altana Pharma/Nycomed
city: Sart-Tilman/Liege 1
country: Belgium
facility: Altana Pharma/Nycomed
city: St. Niklaas
country: Belgium
facility: Altana Pharma/Nycomed
city: Belo Horizonte - Minas Gerais
country: Brazil
facility: Altana Pharma/Nycomed
city: Botucatu - SP CEP
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
country: Brazil
facility: Altana Pharma/Nycomed
city: Ribeirao Preto-SP
country: Brazil
facility: Altana Pharma/Nycomed
city: Abbotsford, BC
country: Canada
facility: Altana Pharma/Nycomed
city: Calgary
country: Canada
facility: Altana Pharma/Nycomed
city: Hamilton
country: Canada
facility: Altana Pharma/Nycomed
city: London
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal, QC
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed
city: Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: St.-Charles Borromee, QC
country: Canada
facility: Altana Pharma/Nycomed
city: Ste Foy
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Windsor
country: Canada
facility: Altana Pharma/Nycomed
city: Winnipeg
country: Canada
facility: Altana Pharma/Nycomed
city: Agen
country: France
facility: Altana Pharma/Nycomed
city: Bobigny
country: France
facility: Altana Pharma/Nycomed
city: Hagondange
country: France
facility: Altana Pharma/Nycomed
city: Joue les Tours
country: France
facility: Altana Pharma/Nycomed
city: Lamballe
country: France
facility: Altana Pharma/Nycomed
city: Marseille
country: France
facility: Altana Pharma/Nycomed
city: Metz
country: France
facility: Altana Pharma/Nycomed
city: Orthez
country: France
facility: Altana Pharma/Nycomed
city: Saint-Mande
country: France
facility: Altana Pharma/Nycomed
city: Toulouse
country: France
facility: Altana Pharma/Nycomed
city: Toul
country: France
facility: Altana Pharma/Nycomed
city: Troyes
country: France
facility: Altana Pharma/Nycomed
city: Bonn
country: Germany
facility: Altana Pharma/Nycomed
city: Burg
country: Germany
facility: Altana Pharma/Nycomed
city: Gardelegen
country: Germany
facility: Altana Pharma/Nycomed
city: Heilbronn
country: Germany
facility: Altana Pharma/Nycomed
city: Hennef
country: Germany
facility: Altana Pharma/Nycomed
city: Ludwigsburg
country: Germany
facility: Altana Pharma/Nycomed
city: Lübeck
country: Germany
facility: Altana Pharma/Nycomed
city: Magdeburg
country: Germany
facility: Altana Pharma/Nycomed
city: Schwerin
country: Germany
facility: Altana Pharma/Nycomed
city: Hong Kong
country: Hong Kong
facility: Altana Pharma/Nycomed
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed
city: Hyderabad
country: India
facility: Altana Pharma/Nycomed
city: Jaipur
country: India
facility: Altana Pharma/Nycomed
city: Madurai
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Mysore
country: India
facility: Altana Pharma/Nycomed
city: Nagpur
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Aviano (Pordenone)
country: Italy
facility: Altana Pharma/Nycomed
city: Bari
country: Italy
facility: Altana Pharma/Nycomed
city: Caserta
country: Italy
facility: Altana Pharma/Nycomed
city: Catania
country: Italy
facility: Altana Pharma/Nycomed
city: Genova
country: Italy
facility: Altana Pharma/Nycomed
city: Mestre (VE)
country: Italy
facility: Altana Pharma/Nycomed
city: Milano
country: Italy
facility: Altana Pharma/Nycomed
city: Napoli
country: Italy
facility: Altana Pharma/Nycomed
city: Parma
country: Italy
facility: Altana Pharma/Nycomed
city: Roma
country: Italy
facility: Altana Pharma/Nycomed
city: Roma
country: Italy
facility: Altana Pharma/Nycomed
city: Roma
country: Italy
facility: Altana Pharma/Nycomed
city: Rozzano (Milano)
country: Italy
facility: Altana Pharma/Nycomed
city: Seoul
country: Korea, Republic of
facility: Altana Pharma/Nycomed
city: Seoul
country: Korea, Republic of
facility: Altana Pharma/Nycomed
city: Seoul
country: Korea, Republic of
facility: Altana Pharma/Nycomed
city: Seoul
country: Korea, Republic of
facility: Altana Pharma/Nycomed
city: Seoul
country: Korea, Republic of
facility: Altana Pharma/Nycomed
city: Kota Kinabalu, Sabah
country: Malaysia
facility: Altana Pharma/Nycomed
city: Kuala Lumpur
country: Malaysia
facility: Altana Pharma/Nycomed
city: Col Del Valle, México D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: Col Del Valle, México D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: Col Héroes de Padierna, México D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: Col. Altavista,Tampico Tamaulipas,Mexico
country: Mexico
facility: Altana Pharma/Nycomed
city: Col. Ex Hacienda Coapa Mexico D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: Héroes de Padierna, México D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: León, Guanajuato Mexico
country: Mexico
facility: Altana Pharma/Nycomed
city: León, Guanajuato
country: Mexico
facility: Altana Pharma/Nycomed
city: Lomas de Chapultepec, México D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: México, D.F.
country: Mexico
facility: Altana Pharma/Nycomed
city: Villahermosa, Tabasco
country: Mexico
facility: Altana Pharma/Nycomed
city: Villahermosa, Tabasco
country: Mexico
facility: Altana Pharma/Nycomed
city: Bialystok
country: Poland
facility: Altana Pharma/Nycomed
city: Katowice
country: Poland
facility: Altana Pharma/Nycomed
city: Lodz
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Amadora
country: Portugal
facility: Altana Pharma/Nycomed
city: Carnaxide
country: Portugal
facility: Altana Pharma/Nycomed
city: Coimbra
country: Portugal
facility: Altana Pharma/Nycomed
city: Lisboa
country: Portugal
facility: Altana Pharma/Nycomed
city: Lisboa
country: Portugal
facility: Altana Pharma/Nycomed
city: Lisboa
country: Portugal
facility: Altana Pharma/Nycomed
city: Santarém
country: Portugal
facility: Altana Pharma/Nycomed
city: Setúbal
country: Portugal
facility: Altana Pharma/Nycomed
city: Viana do Castelo
country: Portugal
facility: Altana Pharma/Nycomed
city: Vila Nova de Gaia
country: Portugal
facility: Altana Pharma/Nycomed
city: Singapore
country: Singapore
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: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama
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
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Castellón de la Plana
country: Spain
facility: Altana Pharma/Nycomed
city: Cordoba
country: Spain
facility: Altana Pharma/Nycomed
city: Cádiz
country: Spain
facility: Altana Pharma/Nycomed
city: Granada
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Pamplona
country: Spain
facility: Altana Pharma/Nycomed
city: Ribeira
country: Spain
facility: Altana Pharma/Nycomed
city: Sevilla
country: Spain
facility: Altana Pharma/Nycomed
city: Basel
country: Switzerland
facility: Altana Pharma/Nycomed
city: Biasca
country: Switzerland
facility: Altana Pharma/Nycomed
city: Biel/Bienne
country: Switzerland
facility: Altana Pharma/Nycomed
city: Lausanne 11 VD
country: Switzerland
facility: Altana Pharma/Nycomed
city: Liestal
country: Switzerland
facility: Altana Pharma/Nycomed
city: Locarno, TI.
country: Switzerland
facility: Altana Pharma/Nycomed
city: Luzern
country: Switzerland
facility: Altana Pharma/Nycomed
city: Payerne
country: Switzerland
facility: Altana Pharma/Nycomed
city: Thun
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
city: Zürich
country: Switzerland
facility: Altana Pharma/Nycomed
city: Taichung
country: Taiwan
facility: Altana Pharma/Nycomed
city: Tainan
country: Taiwan
facility: Altana Pharma/Nycomed
city: Taipei
country: Taiwan
facility: Altana Pharma/Nycomed
city: Bath
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Blackpool
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Middlesex
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Sheffield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Trowbridge
country: United Kingdom
facility: Altana Pharma/Nycomed
Study officials:
affiliation: Medical practice, D-71640 Ludwigsburg, Germany
name: Hans-Joachim Ulmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goh KL, Choi KD, Choi MG, Hsieh TY, Jung HY, Lien HC, Menon J, Mesenas S, Park H, Sheu BS, Wu JC. Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients. BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.
citation: Heading RC, Monnikes H, Tholen A, Schmitt H. Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole. BMC Gastroenterol. 2011 May 11;11:52. doi: 10.1186/1471-230X-11-52.