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

NCT ID: NCT02099708

Last Updated: 2016-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Gastric or Duodenal Ulcers

Keywords

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Pharmacological therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lansoprazole 15 mg

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

Lansoprazole

Intervention Type DRUG

Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg

Interventions

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Lansoprazole

Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg

Intervention Type DRUG

Other Intervention Names

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Takepron Capsules 15 mg, Takepron Orally Disintegrating (OD) Tablets 15 mg

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Postmarketing Group Manager

Role: STUDY_CHAIR

Takeda

Other Identifiers

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JapicCTI-142418

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-R150705

Identifier Type: REGISTRY

Identifier Source: secondary_id

467-713

Identifier Type: -

Identifier Source: org_study_id