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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)

Primary Purpose

Gastroesophageal Reflux, GERD, GORD

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Pantoprazole
Sponsored by
Takeda
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed

Outcomes

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.

Full Information

First Posted
December 2, 2005
Last Updated
May 4, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00261339
Brief Title
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

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Takeda

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, GERD, GORD
Keywords
Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Symptom relief rates
Title
symptom status (compared with pre-treatment)
Title
time to reach first relief from reflux disease related symptoms
Title
time to reach sustained symptom relief
Title
relief rates from reflux disease related complaints
Title
influence of the H. pylori-status on the symptom relief rates
Title
safety.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor of Primary Care
Organizational Affiliation
Centre for Primary and Community Care, Sunderland, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Antrim
ZIP/Postal Code
BT41 3AE
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Ashford
ZIP/Postal Code
TW15 3RN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Aston Clinton, Aylesbury
ZIP/Postal Code
HP22 5LB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Atherstone, Warwick
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Bangor, Northern Ireland
ZIP/Postal Code
BT19 1PP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Barry, Vale of Glamorgan, Cardiff
ZIP/Postal Code
CF63 4HP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Barry
ZIP/Postal Code
CS62 7EB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Bath
ZIP/Postal Code
BA1 2SR
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Bath
ZIP/Postal Code
BA2 4BY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Belfast
ZIP/Postal Code
BT5 7BP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Belfast
ZIP/Postal Code
BT7 1DA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Bexhill-on-Sea, Easr Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Blackpool
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Bradford on Avon, Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Cardiff (Wales)
ZIP/Postal Code
CF14 9BB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Chesterfield
ZIP/Postal Code
S40 1LE
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Chippenham, Wiltshire
ZIP/Postal Code
SN15 2SB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Chippenham
ZIP/Postal Code
SN15 1HP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Cookstown
ZIP/Postal Code
BT80 8BG
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Crawley, West Sussex
ZIP/Postal Code
RH10 1LL
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Crawley
ZIP/Postal Code
RH10 7DX
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Downpatrick, Northern Ireland
ZIP/Postal Code
BT30 6HY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Dronfield
ZIP/Postal Code
S18 1RU
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Ely
ZIP/Postal Code
CF5 4AE
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Hull
ZIP/Postal Code
HU3 3BH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Kent
ZIP/Postal Code
CT5 1BZ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Keresely End, Coventry
ZIP/Postal Code
CV7 8LA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Leigh Lancs
ZIP/Postal Code
WN7 2RB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Leigh on Sea, Essex
ZIP/Postal Code
SS9 2SQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Lisburn
ZIP/Postal Code
BT28 1LU
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
New Street, Ledbury
ZIP/Postal Code
HR8 2DX
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Sheffield
ZIP/Postal Code
S39DA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Sheffield
ZIP/Postal Code
S5 7QB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Slough, Berks
ZIP/Postal Code
SI2 1HD
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Somerset
ZIP/Postal Code
BA111EZ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Southdown, Bath
ZIP/Postal Code
BA2 1NH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
St George's Way, Sunderland
ZIP/Postal Code
SR2 7BW
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Sunbury on Thames, Middlesex
ZIP/Postal Code
TW16 6RH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Trowbridge, Wilts
ZIP/Postal Code
BA14 7EG
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Trowbridge
ZIP/Postal Code
BA14 9AR
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Warminster Wiltshire
ZIP/Postal Code
BA12 9AA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed
City
Watford
ZIP/Postal Code
WD25 0EA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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)

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