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

Overview

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)

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2014

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.

Interventions

  • Drug: Lansoprazole
    • Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of Adverse Drug Reactions
    • Time Frame: 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 Measures

  • Presence or Absence of Endoscopic Examinations
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: From baseline to 12 months
    • Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Postmarketing Group Manager, Study Chair, Takeda

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