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)

Gastroesophageal Reflux Clinical Trial

Official title:

PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261339
• Other study ID #: BY1023/UK-506
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: May 4, 2012
• Start date: August 2005

Study information

• Verified date: December 2006
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• 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

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD
• GORD

Intervention

Drug:
• Pantoprazole

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United Kingdom, 

Outcome

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.