Stomach UlcerPhase 3NCT00787254
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
A Phase 3 study testing Lansoprazole and Gefarnate in people with Stomach Ulcer and Duodenal Ulcer, run by Takeda at 68 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Ulcer, Duodenal Ulcer
- What is being tested?
- Lansoprazole and Gefarnate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 68 sitesJapan
- Study dates
- Apr 2007to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
Japan68 sites
Study site
Asahikawa-shi, Hokkaido
Study site
Beppu-shi, Oita Prefecture
Study site
Chikushi-gun, Fukuoka
Study site
Chitose-shi, Hokkaido
Study site
Chuo-ku, Tokyo
Study site
Daito-shi, Osaka
Study site
Ebino-shi, Miyazaki
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Gifu, Gifu
Study site
Hachioji-shi, Tokyo
Study site
Hakusan-shi, Ishikawa-ken
Study site
Hanyu-shi, Saitama
Study site
Higashihiroshima-shi, Hiroshima
Study site
Hitachi-Naka, Ibaraki
Study site
Ise-shi, Mie-ken
Study site
Kagoshima, Kagoshima-ken
Study site
Kamakura-shi, Kanagawa
Study site
Kasugai-shi, Aichi-ken
Study site
Kato-shi, Hyōgo
Study site
Kawasaki-shi, Kanagawa
Study site
Kiyose-shi, Tokyo
Study site
Kochi, Kochi
Study site
Komatsu-shi, Ishikawa-ken
Study site
Kumamoto, Kumamoto
Study site
Kure-shi, Hiroshima
Study site
Kurume-shi, Fukuoka
Study site
Kyoto, Kyoto
Study site
Machida-shi, Tokyo
Study site
Maebashi, Gunma
Study site
Matsumoto-shi, Nagano
Study site
Matsuyama, Ehime
Study site
Meguro-ku, Tokyo
Study site
Miyazaki, Miyazaki
Study site
Miyazaki-gun, Miyazaki
Study site
Munakata-shi, Fukuoka
Study site
Naruto-shi, Tokushima
Study site
Niigata, Niigata
Study site
Nishi-Tokyo-shi, Tokyo
Study site
Nishinomiya-shi, Hyōgo
Study site
Ogi-shi, Saga-ken
Study site
Okayama, Okayama-ken
Study site
Omura-shi, Nagasaki
Study site
Onga-gun, Fukuoka
Study site
Osaka, Osaka
Study site
Saga, Saga-ken
Study site
Sagamihara-shi, Kanagawa
Study site
Sakai-shi, Osaka
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Shibuya-ku, Tokyo
Study site
Shima-shi, Mie-ken
Study site
Shimonoseki-shi, Yamaguchi
Study site
Shimotsuke-shi, Tochigi
Study site
Shinjuku-ku, Tokyo
Study site
Sunto-gun, Shizuoka
Study site
Susaki-shi, Kochi
Study site
Takamatsu, Kagawa-ken
Study site
Tokushima, Tokushima
Study site
Toshima-ku, Tokyo
Study site
Tottori-shi, Tottori
Study site
Yamato-shi, Kanagawa
Study site
Yanai-shi, Yamaguchi
Study site
Yokkaichi-shi, Mie-ken
Study site
Yokohama, Kanagawa
Study site
Yonago-shi, Tottori
Study site
Yotsukaido-shi, Chiba
Study site
Yuki-shi, Ibaraki
About this study
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
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).
Read the 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.
- Conditions
- Stomach Ulcer, Duodenal Ulcer
- Being tested
- Lansoprazole, Gefarnate
- Keywords
- Curling Ulcer, Gastric Ulcer, Nonsteroid anti-inflammatory drug, Drug Therapy
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called AG-1749
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
GefarnateDrug
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole 15 mg QD | Experimental | Not described Receives: Drug: Lansoprazole |
| Gefarnate 50 mg BID | Active comparator | Not described Receives: Drug: Gefarnate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Measured: 24 Months
Secondary outcomes (47)
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Measured: Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Measured: Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Measured: Baseline and Month 12.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Measured: Baseline and Month 18.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Measured: Baseline and Month 24.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Measured: Baseline and Month 3.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Measured: Baseline and Month 6.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Measured: Baseline and Month 12.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Measured: Baseline and Month 18.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Measured: Baseline and Month 24.
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Measured: On occurrence (up to month 24).
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)
The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)
The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 3.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 6.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 12.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 18.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Measured: Baseline and Month 24.
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.
Measured: Per Incidence (up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stomach UlcerStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787254
- Sponsor's protocol ID
- AG-1749-CCT-352
- Other IDs
- 070495, U1111-1114-2071, R100126
- Status last verified
- Feb 2012
- First submitted
- 6 Nov 2008
- Last updated
- 3 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00787254
- Acronym / sponsor ID
- AG-1749-CCT-352
- Conditions
- Stomach Ulcer, Duodenal Ulcer
- Keywords
- Curling Ulcer, Gastric Ulcer, Nonsteroid anti-inflammatory drug, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole 15 mg QD | Experimental | Drug: Lansoprazole |
| Gefarnate 50 mg BID | Active comparator | Drug: Gefarnate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LansoprazoleAlso: AG-1749Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. | Drug | Lansoprazole 15 mg QD |
| GefarnateGefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months. | Drug | Gefarnate 50 mg BID |
Primary outcome
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
Time frame: 24 Months
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
47 secondary outcomes
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
Time frame: Baseline and Month 24.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
Time frame: Baseline and Month 24.
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Time frame: On occurrence (up to month 24).
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
Time frame: Baseline and Month 18.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)
Time frame: Baseline and Month 24.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
Time frame: Baseline and Month 3.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
Time frame: Baseline and Month 6.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
Time frame: Baseline and Month 18.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Takeda
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lansoprazole and Gefarnate in people with Stomach Ulcer and Duodenal Ulcer, run by Takeda at 68 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.