Clinical trial NCT00261339: 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)
Official title: PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
GERD
GORD
Keywords: Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Pantoprazole
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 300
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Symptom relief rates
measure: symptom status (compared with pre-treatment)
measure: time to reach first relief from reflux disease related symptoms
measure: time to reach sustained symptom relief
measure: relief rates from reflux disease related complaints
measure: influence of the H. pylori-status on the symptom relief rates
measure: safety.
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Ashford
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Aston Clinton, Aylesbury
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Atherstone, Warwick
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Bangor, Northern Ireland
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Barry, Vale of Glamorgan, Cardiff
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Barry
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Bath
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Bath
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Belfast
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Belfast
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Bexhill-on-Sea, Easr Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Blackpool
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Bradford on Avon, Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Cardiff (Wales)
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Chesterfield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Chesterfield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Chippenham, Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Chippenham
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Cookstown
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Crawley, West Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Crawley
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Downpatrick, Northern Ireland
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Dronfield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Ely
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Hull
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Kent
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Keresely End, Coventry
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Leigh Lancs
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Leigh on Sea, Essex
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Lisburn
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Middlesex
country: United Kingdom
facility: Altana Pharma/Nycomed
city: New Street, Ledbury
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Sheffield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Sheffield
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Slough, Berks
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Somerset
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Southdown, Bath
country: United Kingdom
facility: Altana Pharma/Nycomed
city: St George's Way, Sunderland
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Sunbury on Thames, Middlesex
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Trowbridge, Wilts
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Trowbridge
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Warminster Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed
city: Watford
country: United Kingdom
facility: Altana Pharma/Nycomed
Study officials:
affiliation: Centre for Primary and Community Care, Sunderland, United Kingdom
name: Professor of Primary Care
role: PRINCIPAL_INVESTIGATOR
References: