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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Purpose
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: 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 |
- 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
- 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| 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, United Kingdom, CS62 7EB | |
| Altana Pharma/Nycomed | |
| Barry, Vale of Glamorgan, Cardiff, United Kingdom, CF63 4HP | |
| Altana Pharma/Nycomed | |
| Bath, United Kingdom, BA2 4BY | |
| Altana Pharma/Nycomed | |
| Bath, United Kingdom, BA1 2SR | |
| Altana Pharma/Nycomed | |
| Belfast, United Kingdom, BT7 1DA | |
| Altana Pharma/Nycomed | |
| Belfast, United Kingdom, BT5 7BP | |
| 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 4TF | |
| Altana Pharma/Nycomed | |
| Chesterfield, United Kingdom, S40 1LE | |
| Altana Pharma/Nycomed | |
| Chippenham, United Kingdom, SN15 1HP | |
| Altana Pharma/Nycomed | |
| Chippenham, Wiltshire, United Kingdom, SN15 2SB | |
| Altana Pharma/Nycomed | |
| Cookstown, United Kingdom, BT80 8BG | |
| Altana Pharma/Nycomed | |
| Crawley, United Kingdom, RH10 7DX | |
| Altana Pharma/Nycomed | |
| Crawley, West Sussex, United Kingdom, RH10 1LL | |
| 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, United Kingdom, BA14 9AR | |
| Altana Pharma/Nycomed | |
| Trowbridge, Wilts, United Kingdom, BA14 7EG | |
| Altana Pharma/Nycomed | |
| Warminster Wiltshire, United Kingdom, BA12 9AA | |
| Altana Pharma/Nycomed | |
| Watford, United Kingdom, WD25 0EA | |
| Principal Investigator: | Professor of Primary Care | Centre for Primary and Community Care, Sunderland, United Kingdom |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00261339 History of Changes |
| Other Study ID Numbers: | BY1023/UK-506 |
| Study First Received: | December 2, 2005 |
| Last Updated: | May 4, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Gastroesophageal Reflux Gastroesophageal Reflux Disease Pantoprazole |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pantoprazole |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013