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Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

Primary Purpose

Prevention

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention focused on measuring Gastric ulcer, Duodenal ulcer, Low-dose aspirin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esomeprazole 20mg

Placebo

Arm Description

Esomeprazole 20mg once daily oral

Placebo once daily oral

Outcomes

Primary Outcome Measures

Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
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.

Secondary Outcome Measures

Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48
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.
Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.
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.
Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48
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".
Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
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".
Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48
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".
Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week
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".
Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48
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".
Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48
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".
Number of Participants With Adverse Events
Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.

Full Information

First Posted
February 16, 2010
Last Updated
October 24, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01069939
Brief Title
Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention
Keywords
Gastric ulcer, Duodenal ulcer, Low-dose aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole 20mg
Arm Type
Experimental
Arm Description
Esomeprazole 20mg once daily oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily oral
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
20mg, capsule, 72 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, capsule, 72 weeks
Primary Outcome Measure Information:
Title
Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
Description
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.
Time Frame
From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
Secondary Outcome Measure Information:
Title
Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48
Description
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.
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.
Description
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.
Time Frame
12, 24, 36 and 48 weeks
Title
Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48
Description
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".
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
Description
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".
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48
Description
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".
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week
Description
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".
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48
Description
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".
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48
Description
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".
Time Frame
Up to 48 weeks (Baseline to last measurement)
Title
Number of Participants With Adverse Events
Description
Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.
Time Frame
Up to 70 weeks at the longest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kentaro Sugano, MD, PhD
Organizational Affiliation
Jichi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Yotsukaidou
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Kitakyushu-Shi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Onga-Gun
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Yukuhashi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Koriyama
State/Province
Fukushima
Country
Japan
Facility Name
Research Site
City
Nihonmatsu
State/Province
Fukushima
Country
Japan
Facility Name
Research Site
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Kure
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Higashi-ibaraki,
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Komatsu
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Nomi
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
UJI
State/Province
Kyoto
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Daito
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Matsubara
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Minato
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Yao
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Hanyu
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinagawa
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Fukui
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Fukushima
Country
Japan
Facility Name
Research Site
City
Shizuoka
Country
Japan
Facility Name
Research Site
City
Gangneung
State/Province
Gangwon-Do
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Niao-Song-Shiang
State/Province
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Kweishan Shiang
State/Province
Taoyuan Hsien
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Tainan
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24326741
Citation
Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study. Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10.
Results Reference
derived

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Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

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