Clinical trial NCT01069939: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention
Keywords: Gastric ulcer
Duodenal ulcer
Low-dose aspirin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 427
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
timeFrame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
Secondary outcomes:
measure: Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.
timeFrame: 12, 24, 36 and 48 weeks
measure: Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48
timeFrame: Up to 48 weeks (Baseline to last measurement)
measure: Number of Participants With Adverse Events
timeFrame: Up to 70 weeks at the longest
Other outcomes:
Locations:
city: Yotsukaidou
country: Japan
facility: Research Site
state: Chiba
city: Kitakyushu-Shi
country: Japan
facility: Research Site
state: Fukuoka
city: Onga-Gun
country: Japan
facility: Research Site
state: Fukuoka
city: Yukuhashi
country: Japan
facility: Research Site
state: Fukuoka
city: Koriyama
country: Japan
facility: Research Site
state: Fukushima
city: Nihonmatsu
country: Japan
facility: Research Site
state: Fukushima
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Kure
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki
country: Japan
facility: Research Site
state: Hyogo
city: Itami
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Research Site
state: Hyogo
city: Higashi-ibaraki,
country: Japan
facility: Research Site
state: Ibaraki
city: Komatsu
country: Japan
facility: Research Site
state: Ishikawa
city: Nomi
country: Japan
facility: Research Site
state: Ishikawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: UJI
country: Japan
facility: Research Site
state: Kyoto
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Daito
country: Japan
facility: Research Site
state: Osaka
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Matsubara
country: Japan
facility: Research Site
state: Osaka
city: Minato
country: Japan
facility: Research Site
state: Osaka
city: Yao
country: Japan
facility: Research Site
state: Osaka
city: Hanyu
country: Japan
facility: Research Site
state: Saitama
city: Shimotsuke
country: Japan
facility: Research Site
state: Tochigi
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Minato
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Shimonoseki
country: Japan
facility: Research Site
state: Yamaguchi
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Gangneung
country: Korea, Republic of
facility: Research Site
state: Gangwon-Do
city: Wonju-si
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Niao-Song-Shiang
country: Taiwan
facility: Research Site
state: Kaohsiung
city: Kweishan Shiang
country: Taiwan
facility: Research Site
state: Taoyuan Hsien
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: Jichi Medical University
name: Kentaro Sugano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.