Gastroesophageal Reflux Clinical Trial
Official title:
PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
NCT number | NCT00261339 |
Other study ID # | BY1023/UK-506 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | December 2, 2005 |
Last updated | May 4, 2012 |
Start date | August 2005 |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | |
Est. primary completion date | |
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 of age - GERD - Patients with symptoms of GERD Main exclusion criteria: - Signs, indicating other gastrointestinal diseases - Other concomitant diseases - Special restrictions for female patients - Previous medication - Concomitant medication |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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 | 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 | St George`s Way, Sunderland | |
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 |
Lead Sponsor | Collaborator |
---|---|
Takeda |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks of treatment | |||
Secondary | Symptom relief rates | |||
Secondary | symptom status (compared with pre-treatment) | |||
Secondary | time to reach first relief from reflux disease related symptoms | |||
Secondary | time to reach sustained symptom relief | |||
Secondary | relief rates from reflux disease related complaints | |||
Secondary | influence of the H. pylori-status on the symptom relief rates | |||
Secondary | safety. |
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