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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)

This study has been completed.
Information provided by:
Takeda Identifier:
First received: December 2, 2005
Last updated: May 4, 2012
Last verified: December 2006

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.

Condition Intervention Phase
Gastroesophageal Reflux GERD GORD Drug: Pantoprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 Measures:
  • 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
  • influence of the H. pylori-status on the symptom relief rates
  • safety.

Estimated Enrollment: 300
Study Start Date: August 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00261339

United Kingdom
Altana Pharma/Nycomed
Antrim, United Kingdom, BT41 3AE
Altana Pharma/Nycomed
Ashford, United Kingdom, TW15 3RN
Altana Pharma/Nycomed
Aston Clinton, Aylesbury, United Kingdom, HP22 5LB
Altana Pharma/Nycomed
Atherstone, Warwick, United Kingdom, CV9 1EU
Altana Pharma/Nycomed
Bangor, Northern Ireland, United Kingdom, BT19 1PP
Altana Pharma/Nycomed
Barry, Vale of Glamorgan, Cardiff, United Kingdom, CF63 4HP
Altana Pharma/Nycomed
Barry, United Kingdom, CS62 7EB
Altana Pharma/Nycomed
Bath, United Kingdom, BA1 2SR
Altana Pharma/Nycomed
Bath, United Kingdom, BA2 4BY
Altana Pharma/Nycomed
Belfast, United Kingdom, BT5 7BP
Altana Pharma/Nycomed
Belfast, United Kingdom, BT7 1DA
Altana Pharma/Nycomed
Bexhill-on-Sea, Easr Sussex, United Kingdom, TN40 1JJ
Altana Pharma/Nycomed
Blackpool, United Kingdom, FY3 7EN
Altana Pharma/Nycomed
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Altana Pharma/Nycomed
Cardiff (Wales), United Kingdom, CF14 9BB
Altana Pharma/Nycomed
Chesterfield, United Kingdom, S40 1LE
Altana Pharma/Nycomed
Chesterfield, United Kingdom, S40 4TF
Altana Pharma/Nycomed
Chippenham, Wiltshire, United Kingdom, SN15 2SB
Altana Pharma/Nycomed
Chippenham, United Kingdom, SN15 1HP
Altana Pharma/Nycomed
Cookstown, United Kingdom, BT80 8BG
Altana Pharma/Nycomed
Crawley, West Sussex, United Kingdom, RH10 1LL
Altana Pharma/Nycomed
Crawley, United Kingdom, RH10 7DX
Altana Pharma/Nycomed
Downpatrick, Northern Ireland, United Kingdom, BT30 6HY
Altana Pharma/Nycomed
Dronfield, United Kingdom, S18 1RU
Altana Pharma/Nycomed
Ely, United Kingdom, CF5 4AE
Altana Pharma/Nycomed
Glasgow, United Kingdom, G45 9AW
Altana Pharma/Nycomed
Hull, United Kingdom, HU3 3BH
Altana Pharma/Nycomed
Kent, United Kingdom, CT5 1BZ
Altana Pharma/Nycomed
Keresely End, Coventry, United Kingdom, CV7 8LA
Altana Pharma/Nycomed
Leigh Lancs, United Kingdom, WN7 2RB
Altana Pharma/Nycomed
Leigh on Sea, Essex, United Kingdom, SS9 2SQ
Altana Pharma/Nycomed
Lisburn, United Kingdom, BT28 1LU
Altana Pharma/Nycomed
Middlesex, United Kingdom, HA6 2RN
Altana Pharma/Nycomed
New Street, Ledbury, United Kingdom, HR8 2DX
Altana Pharma/Nycomed
Sheffield, United Kingdom, S39DA
Altana Pharma/Nycomed
Sheffield, United Kingdom, S5 7QB
Altana Pharma/Nycomed
Slough, Berks, United Kingdom, SI2 1HD
Altana Pharma/Nycomed
Somerset, United Kingdom, BA111EZ
Altana Pharma/Nycomed
Southdown, Bath, United Kingdom, BA2 1NH
Altana Pharma/Nycomed
St George`s Way, Sunderland, United Kingdom, SR2 7BW
Altana Pharma/Nycomed
Sunbury on Thames, Middlesex, United Kingdom, TW16 6RH
Altana Pharma/Nycomed
Trowbridge, Wilts, United Kingdom, BA14 7EG
Altana Pharma/Nycomed
Trowbridge, United Kingdom, BA14 9AR
Altana Pharma/Nycomed
Warminster Wiltshire, United Kingdom, BA12 9AA
Altana Pharma/Nycomed
Watford, United Kingdom, WD25 0EA
Sponsors and Collaborators
Principal Investigator: Professor of Primary Care Centre for Primary and Community Care, Sunderland, United Kingdom
  More Information Identifier: NCT00261339     History of Changes
Other Study ID Numbers: BY1023/UK-506
Study First Received: December 2, 2005
Last Updated: May 4, 2012

Keywords provided by Takeda:
Gastroesophageal Reflux
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017