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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom relief rates | ||
| symptom status (compared with pre-treatment) | ||
| time to reach first relief from reflux disease related symptoms |
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Main inclusion criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor of Primary Care | Centre for Primary and Community Care, Sunderland, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Antrim | BT41 3AE | United Kingdom | |||
| Altana Pharma/Nycomed |
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| 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. |
| 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 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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