Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
2012년 10월 24일 업데이트: AstraZeneca
A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.
연구 개요
연구 유형
중재적
등록 (실제)
427
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kaohsiung, 대만
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Tainan, 대만
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Taipei, 대만
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Kaohsiung
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Niao-Song-Shiang, Kaohsiung, 대만
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Taoyuan Hsien
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Kweishan Shiang, Taoyuan Hsien, 대만
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Busan, 대한민국
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Seoul, 대한민국
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Gangwon-Do
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Gangneung, Gangwon-Do, 대한민국
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Gangwon-do
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Wonju-si, Gangwon-do, 대한민국
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, 대한민국
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Fukui, 일본
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Fukuoka, 일본
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Fukushima, 일본
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Shizuoka, 일본
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Chiba
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Yotsukaidou, Chiba, 일본
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Fukuoka
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Kitakyushu-Shi, Fukuoka, 일본
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Onga-Gun, Fukuoka, 일본
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Yukuhashi, Fukuoka, 일본
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Fukushima
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Koriyama, Fukushima, 일본
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Nihonmatsu, Fukushima, 일본
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Hiroshima
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Fukuyama, Hiroshima, 일본
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Kure, Hiroshima, 일본
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Hokkaido
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Sapporo, Hokkaido, 일본
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Hyogo
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Amagasaki, Hyogo, 일본
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Itami, Hyogo, 일본
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Kobe, Hyogo, 일본
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Nishinomiya, Hyogo, 일본
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Ibaraki
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Higashi-ibaraki,, Ibaraki, 일본
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Ishikawa
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Komatsu, Ishikawa, 일본
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Nomi, Ishikawa, 일본
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Kanagawa
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Kawasaki-shi, Kanagawa, 일본
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Yokohama, Kanagawa, 일본
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Kyoto
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UJI, Kyoto, 일본
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Miyagi
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Sendai, Miyagi, 일본
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Osaka
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Daito, Osaka, 일본
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Kishiwada, Osaka, 일본
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Matsubara, Osaka, 일본
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Minato, Osaka, 일본
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Yao, Osaka, 일본
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Saitama
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Hanyu, Saitama, 일본
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Tochigi
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Shimotsuke, Tochigi, 일본
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Tokyo
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Chuo, Tokyo, 일본
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Minato, Tokyo, 일본
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Shinagawa, Tokyo, 일본
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Shinjuku, Tokyo, 일본
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Yamaguchi
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Shimonoseki, Yamaguchi, 일본
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Provision of written informed consent before starting the study-related procedures and examinations
- Patients who have the history of gastric and/or duodenal ulcer.
- A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.
Exclusion Criteria:
- Having gastric or duodenal ulcer (except for ulcer scar).
- History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Esomeprazole 20mg
Esomeprazole 20mg once daily oral
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20mg, capsule, 72 weeks
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위약 비교기: Placebo
Placebo once daily oral
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Placebo, capsule, 72 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
기간: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
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Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation.
The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.
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From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48
기간: Up to 48 weeks (Baseline to last measurement)
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Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer).
Higher scores indicate greater severity of gastric mucosal lesion.
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Up to 48 weeks (Baseline to last measurement)
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Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.
기간: 12, 24, 36 and 48 weeks
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Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation.
At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.
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12, 24, 36 and 48 weeks
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Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48
기간: Up to 48 weeks (Baseline to last measurement)
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The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe).
If the value at the last was better in a participant, the participant was categorized into "Improved".
If the value was same, categorised into "Unchanged".
If the value was worsened, categorise into "Worsened".
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Up to 48 weeks (Baseline to last measurement)
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Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
기간: Up to 48 weeks (Baseline to last measurement)
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The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe).
If the value at the last was better in a participant, the participant was categorized into "Improved".
If the value was same, categorised into "Unchanged".
If the value was worsened, categorise into "Worsened".
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Up to 48 weeks (Baseline to last measurement)
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Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48
기간: Up to 48 weeks (Baseline to last measurement)
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The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe).
If the value at the last was better in a participant, the participant was categorized into "Improved".
If the value was same, categorised into "Unchanged".
If the value was worsened, categorise into "Worsened".
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Up to 48 weeks (Baseline to last measurement)
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Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week
기간: Up to 48 weeks (Baseline to last measurement)
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The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe).
If the value at the last was better in a participant, the participant was categorized into "Improved".
If the value was same, categorised into "Unchanged".
If the value was worsened, categorise into "Worsened".
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Up to 48 weeks (Baseline to last measurement)
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Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48
기간: Up to 48 weeks (Baseline to last measurement)
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The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe).
If the value at the last was better in a participant, the participant was categorized into "Improved".
If the value was same, categorised into "Unchanged".
If the value was worsened, categorise into "Worsened".
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Up to 48 weeks (Baseline to last measurement)
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Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48
기간: Up to 48 weeks (Baseline to last measurement)
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The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe).
If the value at the last was better in a participant, the participant was categorized into "Improved".
If the value was same, categorised into "Unchanged".
If the value was worsened, categorise into "Worsened".
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Up to 48 weeks (Baseline to last measurement)
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Number of Participants With Adverse Events
기간: Up to 70 weeks at the longest
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Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.
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Up to 70 weeks at the longest
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Kentaro Sugano, MD, PhD, Jichi Medical University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 2월 1일
기본 완료 (실제)
2011년 11월 1일
연구 완료 (실제)
2011년 11월 1일
연구 등록 날짜
최초 제출
2010년 2월 16일
QC 기준을 충족하는 최초 제출
2010년 2월 16일
처음 게시됨 (추정)
2010년 2월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 11월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 10월 24일
마지막으로 확인됨
2012년 10월 1일
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. .
Esomeprazole에 대한 임상 시험
-
Torrent Pharmaceuticals Limited완전한
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Torrent Pharmaceuticals Limited완전한