- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00363701
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
연구 개요
상세 설명
The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.
In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.
Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.
In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.
We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.
An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.
연구 유형
등록
단계
- 4단계
연락처 및 위치
연구 장소
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Glostrup, 덴마크, 2600
- 모병
- Department of gastroenterology, Glostrup University Hospital
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연락하다:
- Christina Reimer, MD
- 전화번호: 43 23 27 79
- 이메일: chrrei01@glostruphosp.kbhamt.dk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Treatment with PPI in at least 4 months out of the preceding 12.
- Use of PPI in the preceding 10 out of 30 days before inclusion
- Age above 18 years
Exclusion Criteria:
- Erosive Esophagitis
- PPI-treatment as prophylaxis against gastrointestinal bleeding
- PPI-treatment as prophylaxis against ulcers
- PPI-treatment as prophylaxis because of NSAID-treatment
- Pregnant or lactating women
- Previous upper GI surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
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2차 결과 측정
결과 측정 |
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Fraction of patients who are willing to withdraw treatment with PPI
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Fraction of patients who experience symptoms after withdrawal of treatment.
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Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
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Length of time from withdrawal till symptoms arise
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Correlation between levels of gastrin and CgA and time till symptoms arise
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Investigators and patients ability to distinguish between active and placebo treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Peter Bytzer, ass. professor, ph.d, Glostrup University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 001 (Marta Eliza Miller Foundation)
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