Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin

Study Overview

• Status: Completed
• Conditions: Gastric or Duodenal Ulcers
• Intervention / Treatment: Drug: Lansoprazole

Detailed Description

This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin.

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

• Study Type: Observational
• Enrollment (Actual): 3366

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Gastric or duodenal ulcers

Description

Inclusion Criteria:

• (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)

Exclusion Criteria:

• (1) Patients with gastric or duodenal ulcer (in the active [A1, A2] or healing [H1, H2] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lansoprazole 15 mg; Lansoprazole 15 mg orally once daily	Drug: Lansoprazole; Lansoprazole Capsules 15/ OD Tablets; Other Names: Takepron Capsules 15/ OD Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Drug Reactions	Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion	Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.	From baseline to 12 months
Treatment for Gastric/Duodenal Ulcer or Lesion	Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.	From baseline to 12 months
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions	Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.	From baseline to 12 months
Presence or Absence of Endoscopic Examinations	Summary of data on the presence or absence of endoscopic examinations.	From baseline to 12 months
Presence of Gastric or Duodenal Ulcer	Summary of data on the presence or absence of gastric or duodenal ulcers.	From baseline to 12 months
Presence of Gastric or Duodenal Hemorrhagic Lesion	Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.	From baseline to 12 months
Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions	Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.	From baseline to 12 months

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacological therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Recurrence; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 467-712; JapicCTI-142414 (Registry Identifier: JapicCTI); JapicCTI-R150735 (Registry Identifier: JapicCTI)