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

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.

Sponsors

Lead Sponsor: Takeda

Source Takeda
Brief Summary

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

Detailed Description

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

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

Overall Status Terminated
Start Date May 2007
Completion Date November 2008
Primary Completion Date November 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer 18 Months
Secondary Outcome
Measure Time Frame
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) Baseline and Month 9.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) Baseline and Month 12.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) Baseline and Month 18.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) Baseline and Month 3.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) Baseline and Month 6.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) Baseline and Month 9.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) Baseline and Month 12.
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) Baseline and Month 18.
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) 18 Months
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) Baseline and Month 3.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) Baseline and Month 6.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9) Baseline and Month 9.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) Baseline and Month 12.
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) Baseline and Month 18.
Number of Participants With Adverse Events 18 Months
Enrollment 461
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lansoprazole

Description: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.

Arm Group Label: Lansoprazole 15 mg QD

Intervention Type: Drug

Intervention Name: Gefarnate

Description: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Arm Group Label: Gefarnate 50 mg BID

Eligibility

Criteria:

Inclusion Criteria:

- The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.

- The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

- Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.

- Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.

- Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.

- Past or planned surgery affecting gastric acid secretion.

- Clinically significant hepatic or renal disorder.

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
General Manager Study Director Takeda
Location
Facility:
| Matsudo-shi, Chiba, Japan
| Yotsukaido-shi, Chiba, Japan
| Imabari-shi, Ehime, Japan
| Matsuyama-shi, Ehime, Japan
| Fukui-shi, Fukui, Japan
| Fukuoka-shi, Fukuoka, Japan
| Onga-gun, Fukuoka, Japan
| Gifu-shi, Gifu, Japan
| Fujioka-shi, Gunma, Japan
| Maebashi-shi, Gunma, Japan
| Higashihiroshima-shi, Hiroshima, Japan
| Hiroshima-shi, Hiroshima, Japan
| Kure-shi, Hiroshima, Japan
| Asahikawa-shi, Hokkaido, Japan
| Hakodate-shi, Hokkaido, Japan
| Sapporo-shi, Hokkaido, Japan
| Nishinomiya-shi, Hyogo, Japan
| Higashiibaraki-gun, Ibaraki, Japan
| Hitachinaka-shi, Ibaraki, Japan
| Inashiki-gun, Ibaraki, Japan
| Namegata-shi, Ibaraki, Japan
| Tsuchiura-shi, Ibaraki, Japan
| Yuuki-shi, Ibaraki, Japan
| Hakusan-shi, Ishikawa, Japan
| Kanazawa-shi, Ishikawa, Japan
| Komatsu-shi, Ishikawa, Japan
| Takamatsu-shi, Kagawa, Japan
| Fujisawa-shi, Kanagawa, Japan
| Kawasaki-shi, Kanagawa, Japan
| Yamato-shi, Kanagawa, Japan
| Yokohama-shi, Kanagawa, Japan
| Yokosuka-shi, Kanagawa, Japan
| Kochi-shi, Kochi, Japan
| Kumamoto-shi, Kumamoto, Japan
| Kyoto-shi, Kyoto, Japan
| Matsusaka-shi, Mie, Japan
| Shima-shi, Mie, Japan
| Tsu-shi, Mie, Japan
| Sendai-shi, Miyagi, Japan
| Ebino-shi, Miyazaki, Japan
| Miyazaki-shi, Miyazaki, Japan
| Joetsu-shi, Niigata, Japan
| Niigata-shi, Niigata, Japan
| Beppu-shi, Ooita, Japan
| Ooita-shi, Ooita, Japan
| Ibaraki-shi, Osaka, Japan
| Matsubara-shi, Osaka, Japan
| Osaka-shi, Osaka, Japan
| Takatsuki-shi, Osaka, Japan
| Hanyuu-shi, Saitama, Japan
| Ootsu-shi, Shiga, Japan
| Hamada-shi, Shimane, Japan
| Sunto-gun, Shizuoka, Japan
| Shimotsuke-shi, Tochigi, Japan
| Chiyoda-ku, Tokyo, Japan
| Chuuo-ku, Tokyo, Japan
| Hachioji-shi, Tokyo, Japan
| Kiyose-shi, Tokyo, Japan
| Minato-ku, Tokyo, Japan
| Shinagawa-ku, Tokyo, Japan
| Shinjuku-ku, Tokyo, Japan
| Toshima-ku, Tokyo, Japan
| Higashitagawa-gun, Yamagata, Japan
| Iwakuni-shi, Yamaguchi, Japan
| Shimonoseki-shi, Yamaguchi, Japan
Location Countries

Japan

Verification Date

February 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Lansoprazole 15 mg QD

Type: Experimental

Label: Gefarnate 50 mg BID

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov