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

Completed

• Conditions: Gastric or Duodenal Ulcers
• Interventions: Drug: Lansoprazole

• Registration Number: NCT02099708
• Lead Sponsor: Takeda

Brief Summary

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)

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Results First Submitted: 2015-08-06
• Results First Submitted QC: 2015-09-08
• Results First Posted: 2015-10-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3502

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lansoprazole 15 mg	Lansoprazole	Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Drug Reactions	12 months	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.

Secondary Outcome Measures

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