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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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<

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 Summary:

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.


Sponsor: Takeda

Current Primary Outcome: 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.


Original Primary Outcome: Frequency of Adverse Drug Reactions [ Time Frame: 12 months ]

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..


Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Onset of gastric or duodenal ulcers or hemorrhagic lesions after the start of administration of lansoprazole [ Time Frame: From baseline to 12 months ]

Summary of data on the presence or absence of endoscopic examinations, onset of gastric or duodenal ulcers, onset of gastric or duodenal hemorrhagic lesions, and details of treatment and outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.


Information By: Takeda

Dates:
Date Received: March 26, 2014
Date Started: October 2010
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016