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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00261339
Other study ID # BY1023/UK-506
Secondary ID
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
Est. completion date
Est. primary completion date
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


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.
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