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)
PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
1 other identifier
interventional
300
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedMay 7, 2012
December 1, 2006
December 2, 2005
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (7)
Symptom relief rates
symptom 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
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Outpatients of at least 18 years of age
- GERD
- Patients with symptoms of GERD
You may not qualify if:
- Signs, indicating other gastrointestinal diseases
- Other concomitant diseases
- Special restrictions for female patients
- Previous medication
- Concomitant medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (45)
Altana Pharma/Nycomed
Antrim, BT41 3AE, United Kingdom
Altana Pharma/Nycomed
Ashford, TW15 3RN, United Kingdom
Altana Pharma/Nycomed
Aston Clinton, Aylesbury, HP22 5LB, United Kingdom
Altana Pharma/Nycomed
Atherstone, Warwick, CV9 1EU, United Kingdom
Altana Pharma/Nycomed
Bangor, Northern Ireland, BT19 1PP, United Kingdom
Altana Pharma/Nycomed
Barry, CS62 7EB, United Kingdom
Altana Pharma/Nycomed
Barry, Vale of Glamorgan, Cardiff, CF63 4HP, United Kingdom
Altana Pharma/Nycomed
Bath, BA1 2SR, United Kingdom
Altana Pharma/Nycomed
Bath, BA2 4BY, United Kingdom
Altana Pharma/Nycomed
Belfast, BT5 7BP, United Kingdom
Altana Pharma/Nycomed
Belfast, BT7 1DA, United Kingdom
Altana Pharma/Nycomed
Bexhill-on-Sea, Easr Sussex, TN40 1JJ, United Kingdom
Altana Pharma/Nycomed
Blackpool, FY3 7EN, United Kingdom
Altana Pharma/Nycomed
Bradford on Avon, Wiltshire, BA15 1DQ, United Kingdom
Altana Pharma/Nycomed
Cardiff (Wales), CF14 9BB, United Kingdom
Altana Pharma/Nycomed
Chesterfield, S40 1LE, United Kingdom
Altana Pharma/Nycomed
Chesterfield, S40 4TF, United Kingdom
Altana Pharma/Nycomed
Chippenham, SN15 1HP, United Kingdom
Altana Pharma/Nycomed
Chippenham, Wiltshire, SN15 2SB, United Kingdom
Altana Pharma/Nycomed
Cookstown, BT80 8BG, United Kingdom
Altana Pharma/Nycomed
Crawley, RH10 7DX, United Kingdom
Altana Pharma/Nycomed
Crawley, West Sussex, RH10 1LL, United Kingdom
Altana Pharma/Nycomed
Downpatrick, Northern Ireland, BT30 6HY, United Kingdom
Altana Pharma/Nycomed
Dronfield, S18 1RU, United Kingdom
Altana Pharma/Nycomed
Ely, CF5 4AE, United Kingdom
Altana Pharma/Nycomed
Glasgow, G45 9AW, United Kingdom
Altana Pharma/Nycomed
Hull, HU3 3BH, United Kingdom
Altana Pharma/Nycomed
Kent, CT5 1BZ, United Kingdom
Altana Pharma/Nycomed
Keresely End, Coventry, CV7 8LA, United Kingdom
Altana Pharma/Nycomed
Leigh Lancs, WN7 2RB, United Kingdom
Altana Pharma/Nycomed
Leigh on Sea, Essex, SS9 2SQ, United Kingdom
Altana Pharma/Nycomed
Lisburn, BT28 1LU, United Kingdom
Altana Pharma/Nycomed
Middlesex, HA6 2RN, United Kingdom
Altana Pharma/Nycomed
New Street, Ledbury, HR8 2DX, United Kingdom
Altana Pharma/Nycomed
Saint George's Way, Sunderland, SR2 7BW, United Kingdom
Altana Pharma/Nycomed
Sheffield, S39DA, United Kingdom
Altana Pharma/Nycomed
Sheffield, S5 7QB, United Kingdom
Altana Pharma/Nycomed
Slough, Berks, SI2 1HD, United Kingdom
Altana Pharma/Nycomed
Somerset, BA111EZ, United Kingdom
Altana Pharma/Nycomed
Southdown, Bath, BA2 1NH, United Kingdom
Altana Pharma/Nycomed
Sunbury on Thames, Middlesex, TW16 6RH, United Kingdom
Altana Pharma/Nycomed
Trowbridge, BA14 9AR, United Kingdom
Altana Pharma/Nycomed
Trowbridge, Wilts, BA14 7EG, United Kingdom
Altana Pharma/Nycomed
Warminster Wiltshire, BA12 9AA, United Kingdom
Altana Pharma/Nycomed
Watford, WD25 0EA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor of Primary Care
Centre for Primary and Community Care, Sunderland, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 5, 2005
Study Start
August 1, 2005
Last Updated
May 7, 2012
Record last verified: 2006-12