Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312806
• Other study ID #: BY1023/M3-341
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2006
• Last updated: May 4, 2012
• Start date: May 2006
• Est. completion date: July 2007

Study information

• Verified date: December 2008
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: July 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Drug:
• Pantoprazole
Pantoprazole 40 mg o.d.

Locations

Country	Name	City	State
Argentina	Altana Pharma/Nycomed	Buenos Aires
Argentina	Altana Pharma/Nycomed	Buenos Aires
Argentina	Altana Pharma/Nycomed	Buenos Aires
Argentina	Altana Pharma/Nycomed	La Plata
Australia	Altana Pharma/Nycomed	Bedford Park SA
Australia	Altana Pharma/Nycomed	Bondi Junction
Australia	Altana Pharma/Nycomed	Fitzroy
Australia	Altana Pharma/Nycomed	Footscray
Australia	Altana Pharma/Nycomed	Fremantle, WA
Australia	Altana Pharma/Nycomed	Kippa_ring
Australia	Altana Pharma/Nycomed	Melbourne
Australia	Altana Pharma/Nycomed	NSW
Australia	Altana Pharma/Nycomed	Penrith, NSW
Australia	Altana Pharma/Nycomed	Phrahran
Austria	Altana Pharma/Nycomed	Deutschlandsberg
Austria	Altana Pharma/Nycomed	Feldbach
Austria	Altana Pharma/Nycomed	Graz
Austria	Altana Pharma/Nycomed	Krems a. d. Donau
Austria	Altana Pharma/Nycomed	Lilienfeld
Austria	Altana Pharma/Nycomed	St. Pölten
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wien
Belgium	Altana Pharma/Nycomed	Bouge
Belgium	Altana Pharma/Nycomed	Brussels
Belgium	Altana Pharma/Nycomed	Bruxelles
Belgium	Altana Pharma/Nycomed	Bruxelles
Belgium	Altana Pharma/Nycomed	Bruxelles
Belgium	Altana Pharma/Nycomed	Edegem
Belgium	Altana Pharma/Nycomed	Eupen
Belgium	Altana Pharma/Nycomed	Gent
Belgium	Altana Pharma/Nycomed	Jette
Belgium	Altana Pharma/Nycomed	Kortrijk
Belgium	Altana Pharma/Nycomed	Leuven
Belgium	Altana Pharma/Nycomed	Merksem
Belgium	Altana Pharma/Nycomed	Oostende
Belgium	Altana Pharma/Nycomed	Sart-Tilman/Liege 1
Belgium	Altana Pharma/Nycomed	St. Niklaas
Brazil	Altana Pharma/Nycomed	Belo Horizonte - Minas Gerais
Brazil	Altana Pharma/Nycomed	Botucatu - SP CEP
Brazil	Altana Pharma/Nycomed	Campinas - Sao Paulo
Brazil	Altana Pharma/Nycomed	Campinas /SP
Brazil	Altana Pharma/Nycomed	Curitiba-PR
Brazil	Altana Pharma/Nycomed	Ilha do Fundao - Rio de Janeiro - RJ
Brazil	Altana Pharma/Nycomed	Pinheiros Sao Paulo - SP
Brazil	Altana Pharma/Nycomed	Porto Alegre
Brazil	Altana Pharma/Nycomed	Porto Alegre - RS
Brazil	Altana Pharma/Nycomed	Porto Alegre-RS
Brazil	Altana Pharma/Nycomed	Ribeirao Preto-SP
Canada	Altana Pharma/Nycomed	Abbotsford, BC
Canada	Altana Pharma/Nycomed	Calgary
Canada	Altana Pharma/Nycomed	Hamilton
Canada	Altana Pharma/Nycomed	London
Canada	Altana Pharma/Nycomed	Montreal
Canada	Altana Pharma/Nycomed	Montreal, QC
Canada	Altana Pharma/Nycomed	Quebec
Canada	Altana Pharma/Nycomed	St.-Charles Borromee, QC
Canada	Altana Pharma/Nycomed	Ste Foy
Canada	Altana Pharma/Nycomed	Toronto
Canada	Altana Pharma/Nycomed	Toronto
Canada	Altana Pharma/Nycomed	Windsor
Canada	Altana Pharma/Nycomed	Winnipeg
France	Altana Pharma/Nycomed	Agen
France	Altana Pharma/Nycomed	Bobigny
France	Altana Pharma/Nycomed	Hagondange
France	Altana Pharma/Nycomed	Joue les Tours
France	Altana Pharma/Nycomed	Lamballe
France	Altana Pharma/Nycomed	Marseille
France	Altana Pharma/Nycomed	Metz
France	Altana Pharma/Nycomed	Orthez
France	Altana Pharma/Nycomed	Saint-Mande
France	Altana Pharma/Nycomed	Toul
France	Altana Pharma/Nycomed	Toulouse
France	Altana Pharma/Nycomed	Troyes
Germany	Altana Pharma/Nycomed	Bonn
Germany	Altana Pharma/Nycomed	Burg
Germany	Altana Pharma/Nycomed	Gardelegen
Germany	Altana Pharma/Nycomed	Heilbronn
Germany	Altana Pharma/Nycomed	Hennef
Germany	Altana Pharma/Nycomed	Lübeck
Germany	Altana Pharma/Nycomed	Ludwigsburg
Germany	Altana Pharma/Nycomed	Magdeburg
Germany	Altana Pharma/Nycomed	Schwerin
Hong Kong	Altana Pharma/Nycomed	Hong Kong
India	Altana Pharma/Nycomed	Coimbatore
India	Altana Pharma/Nycomed	Coimbatore
India	Altana Pharma/Nycomed	Hyderabad
India	Altana Pharma/Nycomed	Jaipur
India	Altana Pharma/Nycomed	Madurai
India	Altana Pharma/Nycomed	Mumbai
India	Altana Pharma/Nycomed	Mumbai
India	Altana Pharma/Nycomed	Mysore
India	Altana Pharma/Nycomed	Nagpur
India	Altana Pharma/Nycomed	Pune
India	Altana Pharma/Nycomed	Pune
Italy	Altana Pharma/Nycomed	Aviano (Pordenone)
Italy	Altana Pharma/Nycomed	Bari
Italy	Altana Pharma/Nycomed	Caserta
Italy	Altana Pharma/Nycomed	Catania
Italy	Altana Pharma/Nycomed	Genova
Italy	Altana Pharma/Nycomed	Mestre (VE)
Italy	Altana Pharma/Nycomed	Milano
Italy	Altana Pharma/Nycomed	Napoli
Italy	Altana Pharma/Nycomed	Parma
Italy	Altana Pharma/Nycomed	Roma
Italy	Altana Pharma/Nycomed	Roma
Italy	Altana Pharma/Nycomed	Roma
Italy	Altana Pharma/Nycomed	Rozzano (Milano)
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Korea, Republic of	Altana Pharma/Nycomed	Seoul
Malaysia	Altana Pharma/Nycomed	Kota Kinabalu, Sabah
Malaysia	Altana Pharma/Nycomed	Kuala Lumpur
Mexico	Altana Pharma/Nycomed	Col Del Valle, México D.F.
Mexico	Altana Pharma/Nycomed	Col Del Valle, México D.F.
Mexico	Altana Pharma/Nycomed	Col Héroes de Padierna, México D.F.
Mexico	Altana Pharma/Nycomed	Col. Altavista,Tampico Tamaulipas,Mexico
Mexico	Altana Pharma/Nycomed	Col. Ex Hacienda Coapa Mexico D.F.
Mexico	Altana Pharma/Nycomed	Héroes de Padierna, México D.F.
Mexico	Altana Pharma/Nycomed	León, Guanajuato
Mexico	Altana Pharma/Nycomed	León, Guanajuato Mexico
Mexico	Altana Pharma/Nycomed	Lomas de Chapultepec, México D.F.
Mexico	Altana Pharma/Nycomed	México, D.F.
Mexico	Altana Pharma/Nycomed	Villahermosa, Tabasco
Mexico	Altana Pharma/Nycomed	Villahermosa, Tabasco
Poland	Altana Pharma/Nycomed	Bialystok
Poland	Altana Pharma/Nycomed	Katowice
Poland	Altana Pharma/Nycomed	Lodz
Poland	Altana Pharma/Nycomed	Warszawa
Poland	Altana Pharma/Nycomed	Warszawa
Portugal	Altana Pharma/Nycomed	Amadora
Portugal	Altana Pharma/Nycomed	Carnaxide
Portugal	Altana Pharma/Nycomed	Coimbra
Portugal	Altana Pharma/Nycomed	Lisboa
Portugal	Altana Pharma/Nycomed	Lisboa
Portugal	Altana Pharma/Nycomed	Lisboa
Portugal	Altana Pharma/Nycomed	Santarém
Portugal	Altana Pharma/Nycomed	Setúbal
Portugal	Altana Pharma/Nycomed	Viana do Castelo
Portugal	Altana Pharma/Nycomed	Vila Nova de Gaia
Singapore	Altana Pharma/Nycomed	Singapore
South Africa	Altana Pharma/Nycomed	Amanzimtoti
South Africa	Altana Pharma/Nycomed	Berea, Durban
South Africa	Altana Pharma/Nycomed	Bloemfontein
South Africa	Altana Pharma/Nycomed	Cape Town
South Africa	Altana Pharma/Nycomed	Panorama
South Africa	Altana Pharma/Nycomed	Port Elizabeth
South Africa	Altana Pharma/Nycomed	Pretoria
South Africa	Altana Pharma/Nycomed	Somerset-West
Spain	Altana Pharma/Nycomed	Barcelona
Spain	Altana Pharma/Nycomed	Barcelona
Spain	Altana Pharma/Nycomed	Cádiz
Spain	Altana Pharma/Nycomed	Castellón de la Plana
Spain	Altana Pharma/Nycomed	Cordoba
Spain	Altana Pharma/Nycomed	Granada
Spain	Altana Pharma/Nycomed	Madrid
Spain	Altana Pharma/Nycomed	Madrid
Spain	Altana Pharma/Nycomed	Madrid
Spain	Altana Pharma/Nycomed	Pamplona
Spain	Altana Pharma/Nycomed	Ribeira
Spain	Altana Pharma/Nycomed	Sevilla
Switzerland	Altana Pharma/Nycomed	Basel
Switzerland	Altana Pharma/Nycomed	Biasca
Switzerland	Altana Pharma/Nycomed	Biel/Bienne
Switzerland	Altana Pharma/Nycomed	Lausanne 11 VD
Switzerland	Altana Pharma/Nycomed	Liestal
Switzerland	Altana Pharma/Nycomed	Locarno, TI.
Switzerland	Altana Pharma/Nycomed	Luzern
Switzerland	Altana Pharma/Nycomed	Payerne
Switzerland	Altana Pharma/Nycomed	Thun
Switzerland	Altana Pharma/Nycomed	Zürich
Switzerland	Altana Pharma/Nycomed	Zürich
Taiwan	Altana Pharma/Nycomed	Taichung
Taiwan	Altana Pharma/Nycomed	Tainan
Taiwan	Altana Pharma/Nycomed	Taipei
United Kingdom	Altana Pharma/Nycomed	Bath
United Kingdom	Altana Pharma/Nycomed	Blackpool
United Kingdom	Altana Pharma/Nycomed	Glasgow
United Kingdom	Altana Pharma/Nycomed	Middlesex
United Kingdom	Altana Pharma/Nycomed	Sheffield
United Kingdom	Altana Pharma/Nycomed	Trowbridge

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Hong Kong,  India,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™		8 weeks	Yes
Secondary	Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™		4 and 8 weeks	Yes
Secondary	Investigator assessment		4 and 8 weeks	Yes
Secondary	Safety and efficacy		4 and 8 weeks	Yes