Determination of a Questionnaire After Treatment With Pantoprazole at Full Dose and Half Dose in Adult Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/UK-506)
NCT ID: NCT00261339
Last Updated: 2012-05-07
Study Results
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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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2005-08-31
Brief Summary
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Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response to treatment. Therefore, a questionnaire was developed to assess GERD symptoms ('ReQuest TradeMark in Practice'). An important point to consider when using such a questionnaire is to follow the patients´ medical response to treatment and note whether a patient needs to change dosing, such as changing from full dose to half dose, or vice versa.
The aim of the study is to determine the value of the questionnaire ('ReQuest TradeMark in Practice') according to treating physicians' clinical judgment when using pantoprazole at full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and two treatment period (8 weeks each). During the first treatment period, pantoprazole will be administered once daily at full dose (40 mg). During the second treatment period, pantoprazole will be administered once daily at half dose (20 mg). The study will provide further data on safety and tolerability of pantoprazole.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pantoprazole
Eligibility Criteria
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Inclusion Criteria
* Outpatients of at least 18 years of age
* GERD
* Patients with symptoms of GERD
Exclusion Criteria
* Other concomitant diseases
* Special restrictions for female patients
* Previous medication
* Concomitant medication
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Principal Investigators
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Professor of Primary Care
Role: PRINCIPAL_INVESTIGATOR
Centre for Primary and Community Care, Sunderland, United Kingdom
Locations
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Altana Pharma/Nycomed
Antrim, , United Kingdom
Altana Pharma/Nycomed
Ashford, , United Kingdom
Altana Pharma/Nycomed
Aston Clinton, Aylesbury, , United Kingdom
Altana Pharma/Nycomed
Atherstone, Warwick, , United Kingdom
Altana Pharma/Nycomed
Bangor, Northern Ireland, , United Kingdom
Altana Pharma/Nycomed
Barry, , United Kingdom
Altana Pharma/Nycomed
Barry, Vale of Glamorgan, Cardiff, , United Kingdom
Altana Pharma/Nycomed
Bath, , United Kingdom
Altana Pharma/Nycomed
Bath, , United Kingdom
Altana Pharma/Nycomed
Belfast, , United Kingdom
Altana Pharma/Nycomed
Belfast, , United Kingdom
Altana Pharma/Nycomed
Bexhill-on-Sea, Easr Sussex, , United Kingdom
Altana Pharma/Nycomed
Blackpool, , United Kingdom
Altana Pharma/Nycomed
Bradford on Avon, Wiltshire, , United Kingdom
Altana Pharma/Nycomed
Cardiff (Wales), , United Kingdom
Altana Pharma/Nycomed
Chesterfield, , United Kingdom
Altana Pharma/Nycomed
Chesterfield, , United Kingdom
Altana Pharma/Nycomed
Chippenham, , United Kingdom
Altana Pharma/Nycomed
Chippenham, Wiltshire, , United Kingdom
Altana Pharma/Nycomed
Cookstown, , United Kingdom
Altana Pharma/Nycomed
Crawley, , United Kingdom
Altana Pharma/Nycomed
Crawley, West Sussex, , United Kingdom
Altana Pharma/Nycomed
Downpatrick, Northern Ireland, , United Kingdom
Altana Pharma/Nycomed
Dronfield, , United Kingdom
Altana Pharma/Nycomed
Ely, , United Kingdom
Altana Pharma/Nycomed
Glasgow, , United Kingdom
Altana Pharma/Nycomed
Hull, , United Kingdom
Altana Pharma/Nycomed
Kent, , United Kingdom
Altana Pharma/Nycomed
Keresely End, Coventry, , United Kingdom
Altana Pharma/Nycomed
Leigh Lancs, , United Kingdom
Altana Pharma/Nycomed
Leigh on Sea, Essex, , United Kingdom
Altana Pharma/Nycomed
Lisburn, , United Kingdom
Altana Pharma/Nycomed
Middlesex, , United Kingdom
Altana Pharma/Nycomed
New Street, Ledbury, , United Kingdom
Altana Pharma/Nycomed
Saint George's Way, Sunderland, , United Kingdom
Altana Pharma/Nycomed
Sheffield, , United Kingdom
Altana Pharma/Nycomed
Sheffield, , United Kingdom
Altana Pharma/Nycomed
Slough, Berks, , United Kingdom
Altana Pharma/Nycomed
Somerset, , United Kingdom
Altana Pharma/Nycomed
Southdown, Bath, , United Kingdom
Altana Pharma/Nycomed
Sunbury on Thames, Middlesex, , United Kingdom
Altana Pharma/Nycomed
Trowbridge, , United Kingdom
Altana Pharma/Nycomed
Trowbridge, Wilts, , United Kingdom
Altana Pharma/Nycomed
Warminster Wiltshire, , United Kingdom
Altana Pharma/Nycomed
Watford, , United Kingdom
Countries
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Other Identifiers
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BY1023/UK-506
Identifier Type: -
Identifier Source: org_study_id
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