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

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. Proton pump inhibitors such as pantoprazole, can relieve symptoms of GERD in a large proportion of patients.

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.

Detailed Description

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Conditions

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Gastroesophageal Reflux GERD GORD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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
* Outpatients of at least 18 years of age
* GERD
* Patients with symptoms of GERD

Exclusion Criteria

* Signs, indicating other gastrointestinal diseases
* Other concomitant diseases
* Special restrictions for female patients
* Previous medication
* Concomitant medication
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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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

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Altana Pharma/Nycomed

Ashford, , United Kingdom

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Altana Pharma/Nycomed

Aston Clinton, Aylesbury, , United Kingdom

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Altana Pharma/Nycomed

Atherstone, Warwick, , United Kingdom

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Altana Pharma/Nycomed

Bangor, Northern Ireland, , United Kingdom

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Altana Pharma/Nycomed

Barry, , United Kingdom

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Altana Pharma/Nycomed

Barry, Vale of Glamorgan, Cardiff, , United Kingdom

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Altana Pharma/Nycomed

Bath, , United Kingdom

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Altana Pharma/Nycomed

Bath, , United Kingdom

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Altana Pharma/Nycomed

Belfast, , United Kingdom

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Altana Pharma/Nycomed

Belfast, , United Kingdom

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Altana Pharma/Nycomed

Bexhill-on-Sea, Easr Sussex, , United Kingdom

Site Status

Altana Pharma/Nycomed

Blackpool, , United Kingdom

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Altana Pharma/Nycomed

Bradford on Avon, Wiltshire, , United Kingdom

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Altana Pharma/Nycomed

Cardiff (Wales), , United Kingdom

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Altana Pharma/Nycomed

Chesterfield, , United Kingdom

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Altana Pharma/Nycomed

Chesterfield, , United Kingdom

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Altana Pharma/Nycomed

Chippenham, , United Kingdom

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Altana Pharma/Nycomed

Chippenham, Wiltshire, , United Kingdom

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Altana Pharma/Nycomed

Cookstown, , United Kingdom

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Altana Pharma/Nycomed

Crawley, , United Kingdom

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Altana Pharma/Nycomed

Crawley, West Sussex, , United Kingdom

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Altana Pharma/Nycomed

Downpatrick, Northern Ireland, , United Kingdom

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Altana Pharma/Nycomed

Dronfield, , United Kingdom

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Altana Pharma/Nycomed

Ely, , United Kingdom

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Altana Pharma/Nycomed

Glasgow, , United Kingdom

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Altana Pharma/Nycomed

Hull, , United Kingdom

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Altana Pharma/Nycomed

Kent, , United Kingdom

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Altana Pharma/Nycomed

Keresely End, Coventry, , United Kingdom

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Altana Pharma/Nycomed

Leigh Lancs, , United Kingdom

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Altana Pharma/Nycomed

Leigh on Sea, Essex, , United Kingdom

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Altana Pharma/Nycomed

Lisburn, , United Kingdom

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Altana Pharma/Nycomed

Middlesex, , United Kingdom

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Altana Pharma/Nycomed

New Street, Ledbury, , United Kingdom

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Altana Pharma/Nycomed

Saint George's Way, Sunderland, , United Kingdom

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Altana Pharma/Nycomed

Sheffield, , United Kingdom

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Altana Pharma/Nycomed

Sheffield, , United Kingdom

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Altana Pharma/Nycomed

Slough, Berks, , United Kingdom

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Altana Pharma/Nycomed

Somerset, , United Kingdom

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Altana Pharma/Nycomed

Southdown, Bath, , United Kingdom

Site Status

Altana Pharma/Nycomed

Sunbury on Thames, Middlesex, , United Kingdom

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Altana Pharma/Nycomed

Trowbridge, , United Kingdom

Site Status

Altana Pharma/Nycomed

Trowbridge, Wilts, , United Kingdom

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Altana Pharma/Nycomed

Warminster Wiltshire, , United Kingdom

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Altana Pharma/Nycomed

Watford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BY1023/UK-506

Identifier Type: -

Identifier Source: org_study_id

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