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

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ClinicalTrials.gov Identifier: NCT01069939

Recruitment Status : Completed

First Posted : February 17, 2010

Results First Posted : November 22, 2012

Last Update Posted : November 22, 2012

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

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.

Condition or disease	Intervention/treatment	Phase
Prevention	Drug: Esomeprazole Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	427 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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 Start Date :	February 2010
Actual Primary Completion Date :	November 2011
Actual Study Completion Date :	November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin Esomeprazole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily oral	Drug: Esomeprazole 20mg, capsule, 72 weeks
Placebo Comparator: Placebo Placebo once daily oral	Drug: Placebo Placebo, capsule, 72 weeks

Outcome Measures

Primary Outcome Measures :

Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. [ Time Frame: From randomisation to up to 48 weeks (Maximum follow-up period at the 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 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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. [ Time Frame: 12, 24, 36 and 48 weeks ]
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 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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. [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]
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 [ Time Frame: Up to 70 weeks at the longest ]
Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069939

Locations

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Japan
Research Site
Yotsukaidou, Chiba, Japan
Research Site
Kitakyushu-Shi, Fukuoka, Japan
Research Site
Onga-Gun, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Koriyama, Fukushima, Japan
Research Site
Nihonmatsu, Fukushima, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Kure, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki, Hyogo, Japan
Research Site
Itami, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Nishinomiya, Hyogo, Japan
Research Site
Higashi-ibaraki,, Ibaraki, Japan
Research Site
Komatsu, Ishikawa, Japan
Research Site
Nomi, Ishikawa, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
UJI, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Daito, Osaka, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Matsubara, Osaka, Japan
Research Site
Minato, Osaka, Japan
Research Site
Yao, Osaka, Japan
Research Site
Hanyu, Saitama, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Minato, Tokyo, Japan
Research Site
Shinagawa, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Shimonoseki, Yamaguchi, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Shizuoka, Japan
Korea, Republic of
Research Site
Gangneung, Gangwon-Do, Korea, Republic of
Research Site
Wonju-si, Gangwon-do, Korea, Republic of
Research Site
Seongnam-si, Gyeonggi-do, Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Taiwan
Research Site
Niao-Song-Shiang, Kaohsiung, Taiwan
Research Site
Kweishan Shiang, Taoyuan Hsien, Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan

Sponsors and Collaborators

AstraZeneca

Investigators

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Principal Investigator:	Kentaro Sugano, MD, PhD	Jichi Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01069939
Other Study ID Numbers:	D961PC00001
First Posted:	February 17, 2010 Key Record Dates
Results First Posted:	November 22, 2012
Last Update Posted:	November 22, 2012
Last Verified:	October 2012

Keywords provided by AstraZeneca:


Gastric ulcer Duodenal ulcer Low-dose aspirin

Additional relevant MeSH terms:

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Duodenal Ulcer Peptic Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases	Esomeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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