Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

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 Non-steroidal Anti-inflammatory Drugs

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)

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 non-steroidal anti-inflammatory drugs (NSAIDs).

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

• Study Type: Observational
• Enrollment (Actual): 3502

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 NSAIDs for reasons such as pain management for rheumatoid arthritis or osteoarthritis (3) Patients taking oral NSAIDs at the start of administration of lansoprazole (including patients who start NSAIDs 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, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.	Drug: Lansoprazole; Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg; Other Names: Takepron Capsules 15 mg, Takepron Orally Disintegrating (OD) Tablets 15 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Drug Reactions	Frequency was defined as the number of participants for each adverse event 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 or Absence of Endoscopic Examinations	Summary of data on the presence or absence of gastric or duodenal ulcers by using 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 ulcer.	From baseline to 12 months
Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion	Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.	From baseline to 12 months
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
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions	Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. Participants could be counted in more than 1 treatment category.	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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 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): October 27, 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: 467-713; JapicCTI-142418 (Registry Identifier: Japic CTI); JapicCTI-R150705 (Registry Identifier: JapicCTI)