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

Prevention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069939
• Other study ID #: D961PC00001
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2010
• Last updated: October 24, 2012
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Duodenal Ulcer
• Prevention

Intervention

Drug:
• Esomeprazole
20mg, capsule, 72 weeks
• Placebo
Placebo, capsule, 72 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)	No
Secondary	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.	Up to 48 weeks (Baseline to last measurement)	No
Secondary	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.	12, 24, 36 and 48 weeks	No
Secondary	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".	Up to 48 weeks (Baseline to last measurement)	No
Secondary	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".	Up to 48 weeks (Baseline to last measurement)	No
Secondary	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".	Up to 48 weeks (Baseline to last measurement)	No
Secondary	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".	Up to 48 weeks (Baseline to last measurement)	No
Secondary	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".	Up to 48 weeks (Baseline to last measurement)	No
Secondary	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".	Up to 48 weeks (Baseline to last measurement)	No
Secondary	Number of Participants With Adverse Events	Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.	Up to 70 weeks at the longest	Yes