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

Sponsor:	Takeda Pharmaceutical Company Limited
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00762359

Purpose

The purpose of this study is to determine whether lansoprazole is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

Condition	Intervention	Phase
Stomach Ulcer Duodenal Ulcer	Drug: lansoprazole Drug: gefarnate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy 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.

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Gefarnate Lansoprazole

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Rate of recurrence of gastric ulcer and/or duodenal ulcer. [ Time Frame: Final Visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of onset of gastric and duodenal mucosal injury, hemorrhagic lesions and gastrointestinal symptoms. [ Time Frame: At all visits. ] [ Designated as safety issue: No ]
Adverse events. [ Time Frame: At all visits. ] [ Designated as safety issue: Yes ]

Enrollment:	461
Study Start Date:	May 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: lansoprazole Lansoprazole 15 mg, tablets, orally, once daily and gefarnate placebo-matching tablets, orally, twice daily for up to 12 to 30 months.
2: Active Comparator	Drug: gefarnate Lansoprazole placebo-matching tablets, orally, once daily and gefarnate 50 mg, tablets, orally, twice daily for up to 12 to 30 months.

Detailed Description:

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

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Is 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.
Is confirmed to have a history of gastric ulcer or duodenal ulcer (combined gastric and duodenal ulcer is also possible).

Exclusion Criteria:

Has gastric and/or duodenal ulcer just before study drug administration.
The patient has active upper gastrointestinal bleeding just before study drug administration.
Has aspirin-induced asthma, hypersensitivity towards nonsteroidal anti-inflammatory drugs or a history of it.
Has undergone or is scheduled to undergo surgery that will affect gastric secretion.
Has clinically apparent liver or kidney disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762359

Show 65 Study Locations

Sponsors and Collaborators

Takeda Pharmaceutical Company Limited

Investigators

Study Director:

General Manager

Takeda Pharmaceutical Company Limited

More Information

Additional Information:

PREVACID® Package Insert This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Takeda Pharmaceutical Company Limited ( General Manager )
Study ID Numbers:	AG-1749-CCT-351, CTI-070494(ja)
Study First Received:	September 26, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00762359 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Takeda Global Research & Development Center, Inc.:

Curling Ulcer
Gastric Ulcer
Aspirin
Acetylsalicylic Acid
Drug Therapy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Pathologic Processes
Stomach Diseases
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Gefarnate

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Duodenal Diseases
Peptic Ulcer
Stomach Ulcer
Ulcer
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Enzyme Inhibitors
Cardiovascular Agents
Intestinal Diseases
Pharmacologic Actions
Duodenal Ulcer
Digestive System Diseases
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 08, 2010