Stomach UlcerPhase 3NCT00762359

A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers

A Phase 3 study testing Lansoprazole and Gefarnate in people with Stomach Ulcer and Duodenal Ulcer, run by Takeda at 65 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. 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: 461 participants
Where: 65 sitesJapan
Study dates: May 2007to Nov 2008
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 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.

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 nonsteroidal anti-inflammatory drugs.
Past or planned surgery affecting gastric acid secretion.
Clinically significant hepatic or renal disorder.

Trial locations and contacts

65 sites in 1 country.

City, postcode or hospital

65 sites in 1 country

Japan65 sites

Study site
Asahikawa-shi, Hokkaido
Study site
Beppu-shi, Ooita
Study site
Chiyoda-ku, Tokyo
Study site
Chuuo-ku, Tokyo
Study site
Ebino-shi, Miyazaki
Study site
Fujioka-shi, Gunma
Study site
Fujisawa-shi, Kanagawa
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Gifu, Gifu
Study site
Hachioji-shi, Tokyo
Study site
Hakodate-shi, Hokkaido
Study site
Hakusan-shi, Ishikawa-ken
Study site
Hamada-shi, Shimane
Study site
Hanyuu-shi, Saitama
Study site
Higashihiroshima-shi, Hiroshima
Study site
Higashiibaraki-gun, Ibaraki
Study site
Higashitagawa-gun, Yamagata
Study site
Hiroshima, Hiroshima
Study site
Hitachi-Naka, Ibaraki
Study site
Ibaraki-shi, Osaka
Study site
Imabari, Ehime
Study site
Inashiki-gun, Ibaraki
Study site
Iwakuni-shi, Yamaguchi
Study site
Jōetsu, Niigata
Study site
Kanazawa, Ishikawa-ken
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
Kyoto, Kyoto
Study site
Maebashi, Gunma
Study site
Matsubara-shi, Osaka
Study site
Matsudo-shi, Chiba
Study site
Matsusaka-shi, Mie-ken
Study site
Matsuyama, Ehime
Study site
Minato-ku, Tokyo
Study site
Miyazaki, Miyazaki
Study site
Namegata-shi, Ibaraki
Study site
Niigata, Niigata
Study site
Nishinomiya-shi, Hyōgo
Study site
Ōita, Ooita
Study site
Onga-gun, Fukuoka
Study site
Osaka, Osaka
Study site
Ōtsu, Shiga
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Shima-shi, Mie-ken
Study site
Shimonoseki-shi, Yamaguchi
Study site
Shimotsuke-shi, Tochigi
Study site
Shinagawa-ku, Tokyo
Study site
Shinjuku-ku, Tokyo
Study site
Sunto-gun, Shizuoka
Study site
Takamatsu, Kagawa-ken
Study site
Takatsuki-shi, Osaka
Study site
Toshima-ku, Tokyo
Study site
Tsu, Mie-ken
Study site
Tsuchiura-shi, Ibaraki
Study site
Yamato-shi, Kanagawa
Study site
Yokohama, Kanagawa
Study site
Yokosuka-shi, Kanagawa
Study site
Yotsukaido-shi, Chiba
Study site
Yuuki-shi, Ibaraki

Other trials in Japan

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 Low Dose Aspirin.

Read the 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.

Conditions: Stomach Ulcer, Duodenal Ulcer
Being tested: Lansoprazole, Gefarnate
Keywords: Curling Ulcer, Gastric Ulcer, Aspirin, Acetylsalicylic Acid, 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, PREVACID®, Takepron®
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
GefarnateDrug
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Study groups in NCT00762359
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 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Measured: 18 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 9)
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 9.
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 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 9)
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 9.
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.
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 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Measured: 18 Months
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
Postprandial pain 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)
Postprandial pain 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 9)
Postprandial pain 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 9.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
Postprandial pain 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)
Postprandial pain 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 3)
Hunger and nighttime pain 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)
Hunger and nighttime pain 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 9)
Hunger and nighttime pain 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 9.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
Hunger and nighttime pain 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)
Hunger and nighttime pain 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 3)
Feeling of enlarged abdomen 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)
Feeling of enlarged abdomen 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 9)
Feeling of enlarged abdomen 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 9.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
Feeling of enlarged abdomen 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)
Feeling of enlarged abdomen 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 3)
Feeling of nausea 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)
Feeling of nausea 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 9)
Feeling of nausea 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 9.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
Feeling of nausea 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)
Feeling of nausea 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 3)
Feeling of heartburn 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)
Feeling of heartburn 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 9)
Feeling of heartburn 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 9.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
Feeling of heartburn 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)
Feeling of heartburn 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 3)
Severity of anorexia 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)
Severity of anorexia 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 9)
Severity of anorexia 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 9.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Severity of anorexia 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)
Severity of anorexia 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 3)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) 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)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) 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 9)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) 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 9.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) 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)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) 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.
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: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Nov 2008

First posted30 Sep 2008 (estimated)
Study startMay 2007
Primary completionNov 2008
Study completionNov 2008

Why it stopped: AG-1749 superior to Gefarnate in ulcer prevention

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: 461 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762359
Sponsor's protocol ID: AG-1749-CCT-351
Other IDs: 070494, U1111-1113-9929, R100125
Status last verified: Feb 2012
First submitted: 26 Sep 2008
Last updated: 3 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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 Low Dose Aspirin.
ClinicalTrials.gov ID: NCT00762359
Acronym / sponsor ID: AG-1749-CCT-351
Conditions: Stomach Ulcer, Duodenal Ulcer
Keywords: Curling Ulcer, Gastric Ulcer, Aspirin, Acetylsalicylic Acid, Drug Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: AG-1749 superior to Gefarnate in ulcer prevention
Enrolment: 461 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 30 Sep 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.

Detailed description

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.

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 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.

Key exclusion criteria (5 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 nonsteroidal anti-inflammatory drugs.
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-1749, PREVACID®, Takepron®Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.	Drug	Lansoprazole 15 mg QD
GefarnateGefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.	Drug	Gefarnate 50 mg BID

Primary outcome

Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
Time frame: 18 Months
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 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 9)
Time frame: Baseline and Month 9.
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 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 9)
Time frame: Baseline and Month 9.
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.
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Time frame: 18 Months
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 9)
Time frame: Baseline and Month 9.
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 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 9)
Time frame: Baseline and Month 9.
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 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 9)
Time frame: Baseline and Month 9.
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 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 9)
Time frame: Baseline and Month 9.
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 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 9)
Time frame: Baseline and Month 9.
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 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 9)
Time frame: Baseline and Month 9.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Time frame: Baseline and Month 12.

Results and safety

Results posted to the registry on 10 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lansoprazole 15 mg QD	226	167
Gefarnate 50 mg BID	235	178

Primary outcome: Number of Participants With Gastric Ulcer and/or Duodenal Ulcer

Time frame: 18 Months. Number. Unit: participants

Measure	Lansoprazole 15 mg QD n = 226	Gefarnate 50 mg BID n = 234
Value	6	53

Lansoprazole 15 mg QD vs Gefarnate 50 mg BID: Hazard Ratio (HR): 0.0989 (95% CI 0.0425 to 0.2300), p <0.0001, Log Rank

Population analysed: Participants not taking investigational drug were not included.

47 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lansoprazole 15 mg QD	27 of 226 (11.9%)	82 of 226 (36.3%)	Not reported
Gefarnate 50 mg BID	26 of 234 (11.1%)	68 of 234 (29.1%)	Not reported

Limitations and caveats (from the sponsor): On September 2008, the Efficacy and Safety Evaluation Committee recommended that this study be discontinued based on the interim analysis.

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

65 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 65 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 5 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: stopped early, 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 65 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: 18 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00762359.

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.