Clinical Trial: Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
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 in Pat
Brief Summary: The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
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 low-dose aspirin.
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 ]
Original Primary Outcome: Same as current
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 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 ulcers.
- Presence 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 lesions.
- 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 (Including Duplicates) 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.
- 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 ]
Information By: Takeda
Dates:
Date Received: March 26, 2014
Date Started: August 2010
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016