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

NCT01069939 | Completed Phase 3 Results DMC

• 1 other identifier: D961PC00001
• Study Type: interventional
• Target: 427
• Locations: 3 countries
• Sites: 46

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.

Conditions

Prevention

Keywords

Gastric ulcer; Duodenal ulcer; Low-dose aspirin

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48

  Up to 48 weeks (Baseline to last measurement)

• Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.

  12, 24, 36 and 48 weeks

• Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48

  Up to 48 weeks (Baseline to last measurement)

• Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.

  Up to 48 weeks (Baseline to last measurement)

• Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48

  Up to 48 weeks (Baseline to last measurement)

Study Arms (2)

Esomeprazole 20mg

EXPERIMENTAL

Esomeprazole 20mg once daily oral

Drug: Esomeprazole

Placebo

PLACEBO COMPARATOR

Placebo once daily oral

Drug: Placebo

Interventions

Esomeprazole DRUG

20mg, capsule, 72 weeks

Esomeprazole 20mg

Placebo DRUG

Placebo, capsule, 72 weeks

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having gastric or duodenal ulcer (except for ulcer scar).
• History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (46)

Research Site

Yotsukaidou, Chiba, Japan

Location

Research Site

Fukui-shi, Fukui, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

Research Site

Kitakyushu-Shi, Fukuoka, Japan

Location

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Onga-Gun, Fukuoka, Japan

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Yukuhashi, Fukuoka, Japan

Location

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Fukushima, Fukushima, Japan

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Kōriyama, Fukushima, Japan

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Nihommatsu, Fukushima, Japan

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Fukuyama, Hiroshima, Japan

Location

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Kure, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Itami, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Higashi-ibaraki,, Ibaraki, Japan

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Komatsu, Ishikawa-ken, Japan

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Nomi, Ishikawa-ken, 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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Daitō, 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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Hanyū, Saitama, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuke, Tochigi, Japan

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Chūō, 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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Gangneung, Gangwon-do, South Korea

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Research Site

Wŏnju, Gangwon-do, South Korea

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Seongnam-si, Gyeonggi-do, South Korea

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Busan, South Korea

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Seoul, South Korea

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Research Site

Niao-Song-Shiang, Kaohsiung, Taiwan

Location

Research Site

Kweishan Shiang, Taoyuan Hsien, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24326741 DERIVED

MeSH Terms

Conditions

Stomach Ulcer; Duodenal Ulcer

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Kentaro Sugano, MD, PhD

  Jichi Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 22, 2012
• Results First Posted: November 22, 2012

Record last verified: 2012-10

Locations

KR (5); TW (5); JP (36)