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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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