Clinical trial NCT00762359: A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Official title: A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric And Duodenal Ulcers During Long-Term Treatment With Low Dose Aspirin.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stomach Ulcer
Duodenal Ulcer
Keywords: Curling Ulcer
Gastric Ulcer
Aspirin
Acetylsalicylic Acid
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 461
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

Detailed description: In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.

Eligibility criteria: Inclusion Criteria:

* The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
* The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

* Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
* Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
* Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
* Past or planned surgery affecting gastric acid secretion.
* Clinically significant hepatic or renal disorder.

Primary outcomes:
measure: Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
timeFrame: 18 Months
Secondary outcomes:
measure: Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
timeFrame: Baseline and Month 18.
measure: Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
timeFrame: 18 Months
measure: Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
timeFrame: Baseline and Month 3.
measure: Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
timeFrame: Baseline and Month 6.
measure: Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)
timeFrame: Baseline and Month 9.
measure: Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
timeFrame: Baseline and Month 12.
measure: Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
timeFrame: Baseline and Month 18.
measure: Number of Participants With Adverse Events
timeFrame: 18 Months
Other outcomes:
Locations:
city: Matsudo-shi
country: Japan
state: Chiba
city: Yotsukaido-shi
country: Japan
state: Chiba
city: Imabari-shi
country: Japan
state: Ehime
city: Matsuyama-shi
country: Japan
state: Ehime
city: Fukui-shi
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Gifu-shi
country: Japan
state: Gifu
city: Fujioka-shi
country: Japan
state: Gunma
city: Maebashi-shi
country: Japan
state: Gunma
city: Higashihiroshima-shi
country: Japan
state: Hiroshima
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Kure-shi
country: Japan
state: Hiroshima
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Hakodate-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Higashiibaraki-gun
country: Japan
state: Ibaraki
city: Hitachinaka-shi
country: Japan
state: Ibaraki
city: Inashiki-gun
country: Japan
state: Ibaraki
city: Namegata-shi
country: Japan
state: Ibaraki
city: Tsuchiura-shi
country: Japan
state: Ibaraki
city: Yuuki-shi
country: Japan
state: Ibaraki
city: Hakusan-shi
country: Japan
state: Ishikawa
city: Kanazawa-shi
country: Japan
state: Ishikawa
city: Komatsu-shi
country: Japan
state: Ishikawa
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Fujisawa-shi
country: Japan
state: Kanagawa
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Yamato-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Yokosuka-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Matsusaka-shi
country: Japan
state: Mie
city: Shima-shi
country: Japan
state: Mie
city: Tsu-shi
country: Japan
state: Mie
city: Sendai-shi
country: Japan
state: Miyagi
city: Ebino-shi
country: Japan
state: Miyazaki
city: Miyazaki-shi
country: Japan
state: Miyazaki
city: Joetsu-shi
country: Japan
state: Niigata
city: Niigata-shi
country: Japan
state: Niigata
city: Beppu-shi
country: Japan
state: Ooita
city: Ooita-shi
country: Japan
state: Ooita
city: Ibaraki-shi
country: Japan
state: Osaka
city: Matsubara-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Takatsuki-shi
country: Japan
state: Osaka
city: Hanyuu-shi
country: Japan
state: Saitama
city: Ootsu-shi
country: Japan
state: Shiga
city: Hamada-shi
country: Japan
state: Shimane
city: Sunto-gun
country: Japan
state: Shizuoka
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuuo-ku
country: Japan
state: Tokyo
city: Hachioji-shi
country: Japan
state: Tokyo
city: Kiyose-shi
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Higashitagawa-gun
country: Japan
state: Yamagata
city: Iwakuni-shi
country: Japan
state: Yamaguchi
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda
name: General Manager
role: STUDY_DIRECTOR
References: