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)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux; GERD; GORD
Intervention: Pantoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Professor of Primary Care, Principal Investigator, Affiliation: Centre for Primary and Community Care, Sunderland, United Kingdom
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.
Clinical Details
Official title: PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: 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 outcome: Symptom relief ratessymptom status (compared with pre-treatment) time to reach first relief from reflux disease related symptoms time to reach sustained symptom relief relief rates from reflux disease related complaints influence of the H. pylori-status on the symptom relief rates safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
ALTANA Pharma, Cities in the UK, United Kingdom
Additional Information
Starting date: August 2005
Last updated: December 15, 2006
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