Clinical trial NCT00787254: Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
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 Nonsteroid Anti-inflammatory Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomach Ulcer
Duodenal Ulcer
Keywords: Curling Ulcer
Gastric Ulcer
Nonsteroid anti-inflammatory drug
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 366
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 AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).

Detailed description: In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of 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 nonsteroid anti-inflammatory medication.

Eligibility criteria: Inclusion Criteria:

* The patient was on nonsteroid anti-inflammatory drug (NSAID) 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 NSAIDs.
* Past or planned surgery affecting gastric acid secretion.
* Clinically significant hepatic or renal disorder.
* Serious cardiac dysfunction, hypertension, or hematological disorder.

Primary outcomes:
measure: Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
timeFrame: 24 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 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 Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
timeFrame: Baseline and Month 24.
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 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: Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
timeFrame: Baseline and Month 24.
measure: Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
timeFrame: On occurrence (up to month 24).
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 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 Postprandial Pain Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
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 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 Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
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 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 Enlarged Abdomen Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
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 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 Nausea Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
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 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 Feeling of Heartburn Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
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 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 Anorexia Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
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 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: Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)
timeFrame: Baseline and Month 24.
measure: Number of Participants With Adverse Events
timeFrame: Per Incidence (up to 24 months).
Other outcomes:
Locations:
city: Kasugai-shi
country: Japan
state: Aichi
city: Yotsukaido-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Fukui-shi
country: Japan
state: Fukui
city: Chikushi-gun
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kurume-shi
country: Japan
state: Fukuoka
city: Munakata-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Gifu-shi
country: Japan
state: Gifu
city: Maebashi-shi
country: Japan
state: Gunma
city: Higashihiroshima-shi
country: Japan
state: Hiroshima
city: Kure-shi
country: Japan
state: Hiroshima
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Chitose-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kato-shi
country: Japan
state: Hyogo
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Hitachinaka-shi
country: Japan
state: Ibaraki
city: Yuki-shi
country: Japan
state: Ibaraki
city: Hakusan-shi
country: Japan
state: Ishikawa
city: Komatsu-shi
country: Japan
state: Ishikawa
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Yamato-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Susaki-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Ise-shi
country: Japan
state: Mie
city: Shima-shi
country: Japan
state: Mie
city: Yokkaichi-shi
country: Japan
state: Mie
city: Sendai-shi
country: Japan
state: Miyagi
city: Ebino-shi
country: Japan
state: Miyazaki
city: Miyazaki-gun
country: Japan
state: Miyazaki
city: Miyazaki-shi
country: Japan
state: Miyazaki
city: Matsumoto-shi
country: Japan
state: Nagano
city: Omura-shi
country: Japan
state: Nagasaki
city: Niigata-shi
country: Japan
state: Niigata
city: Beppu-shi
country: Japan
state: Oita
city: Okayama-shi
country: Japan
state: Okayama
city: Daito-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Ogi-shi
country: Japan
state: Saga
city: Saga-shi
country: Japan
state: Saga
city: Hanyu-shi
country: Japan
state: Saitama
city: Sunto-gun
country: Japan
state: Shizuoka
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Naruto-shi
country: Japan
state: Tokushima
city: Tokushima-shi
country: Japan
state: Tokushima
city: Chuo-ku
country: Japan
state: Tokyo
city: Hachioji-shi
country: Japan
state: Tokyo
city: Kiyose-shi
country: Japan
state: Tokyo
city: Machida-shi
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Nishitokyo-shi
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Tottori-shi
country: Japan
state: Tottori
city: Yonago-shi
country: Japan
state: Tottori
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
city: Yanai-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda
name: General Manager
role: STUDY_DIRECTOR
References: