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)
PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
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.
연구 개요
연구 유형
등록
단계
- 4단계
연락처 및 위치
연구 장소
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Antrim, 영국, BT41 3AE
- Altana Pharma/Nycomed
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Ashford, 영국, TW15 3RN
- Altana Pharma/Nycomed
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Aston Clinton, Aylesbury, 영국, HP22 5LB
- Altana Pharma/Nycomed
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Atherstone, Warwick, 영국, CV9 1EU
- Altana Pharma/Nycomed
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Bangor, Northern Ireland, 영국, BT19 1PP
- Altana Pharma/Nycomed
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Barry, 영국, CS62 7EB
- Altana Pharma/Nycomed
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Barry, Vale of Glamorgan, Cardiff, 영국, CF63 4HP
- Altana Pharma/Nycomed
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Bath, 영국, BA1 2SR
- Altana Pharma/Nycomed
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Bath, 영국, BA2 4BY
- Altana Pharma/Nycomed
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Belfast, 영국, BT5 7BP
- Altana Pharma/Nycomed
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Belfast, 영국, BT7 1DA
- Altana Pharma/Nycomed
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Bexhill-on-Sea, Easr Sussex, 영국, TN40 1JJ
- Altana Pharma/Nycomed
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Blackpool, 영국, FY3 7EN
- Altana Pharma/Nycomed
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Bradford on Avon, Wiltshire, 영국, BA15 1DQ
- Altana Pharma/Nycomed
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Cardiff (Wales), 영국, CF14 9BB
- Altana Pharma/Nycomed
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Chesterfield, 영국, S40 1LE
- Altana Pharma/Nycomed
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Chesterfield, 영국, S40 4TF
- Altana Pharma/Nycomed
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Chippenham, 영국, SN15 1HP
- Altana Pharma/Nycomed
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Chippenham, Wiltshire, 영국, SN15 2SB
- Altana Pharma/Nycomed
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Cookstown, 영국, BT80 8BG
- Altana Pharma/Nycomed
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Crawley, 영국, RH10 7DX
- Altana Pharma/Nycomed
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Crawley, West Sussex, 영국, RH10 1LL
- Altana Pharma/Nycomed
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Downpatrick, Northern Ireland, 영국, BT30 6HY
- Altana Pharma/Nycomed
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Dronfield, 영국, S18 1RU
- Altana Pharma/Nycomed
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Ely, 영국, CF5 4AE
- Altana Pharma/Nycomed
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Glasgow, 영국, G45 9AW
- Altana Pharma/Nycomed
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Hull, 영국, HU3 3BH
- Altana Pharma/Nycomed
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Kent, 영국, CT5 1BZ
- Altana Pharma/Nycomed
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Keresely End, Coventry, 영국, CV7 8LA
- Altana Pharma/Nycomed
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Leigh Lancs, 영국, WN7 2RB
- Altana Pharma/Nycomed
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Leigh on Sea, Essex, 영국, SS9 2SQ
- Altana Pharma/Nycomed
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Lisburn, 영국, BT28 1LU
- Altana Pharma/Nycomed
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Middlesex, 영국, HA6 2RN
- Altana Pharma/Nycomed
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New Street, Ledbury, 영국, HR8 2DX
- Altana Pharma/Nycomed
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Sheffield, 영국, S39DA
- Altana Pharma/Nycomed
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Sheffield, 영국, S5 7QB
- Altana Pharma/Nycomed
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Slough, Berks, 영국, SI2 1HD
- Altana Pharma/Nycomed
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Somerset, 영국, BA111EZ
- Altana Pharma/Nycomed
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Southdown, Bath, 영국, BA2 1NH
- Altana Pharma/Nycomed
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St George's Way, Sunderland, 영국, SR2 7BW
- Altana Pharma/Nycomed
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Sunbury on Thames, Middlesex, 영국, TW16 6RH
- Altana Pharma/Nycomed
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Trowbridge, 영국, BA14 9AR
- Altana Pharma/Nycomed
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Trowbridge, Wilts, 영국, BA14 7EG
- Altana Pharma/Nycomed
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Warminster Wiltshire, 영국, BA12 9AA
- Altana Pharma/Nycomed
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Watford, 영국, WD25 0EA
- Altana Pharma/Nycomed
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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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
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2차 결과 측정
결과 측정 |
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Symptom relief rates
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symptom status (compared with pre-treatment)
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time to reach first relief from reflux disease related symptoms
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time to reach sustained symptom relief
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relief rates from reflux disease related complaints
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influence of the H. pylori-status on the symptom relief rates
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안전.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Professor of Primary Care, Centre for Primary and Community Care, Sunderland, United Kingdom
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
판토프라졸에 대한 임상 시험
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Mohamed SaadAbbott Nutrition; University of Louisville완전한