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

Gastric or Duodenal Ulcers Clinical Trial

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 Patients Receiving Non-steroidal Anti-inflammatory Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099708
• Other study ID #: 467-713
• Secondary ID: JapicCTI-142418
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: September 8, 2015
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3502
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastric or Duodenal Ulcers
• Ulcer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Drug Reactions	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.	12 months	No
Secondary	Presence or Absence of Endoscopic Examinations	Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.	From baseline to 12 months	No
Secondary	Presence of Gastric or Duodenal Ulcer	Summary of data on the presence or absence of gastric or duodenal ulcer.	From baseline to 12 months	No
Secondary	Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion	Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.	From baseline to 12 months	No
Secondary	Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion	Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.	From baseline to 12 months	No
Secondary	Treatment for Gastric/Duodenal Ulcer or Lesion	Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.	From baseline to 12 months	No
Secondary	Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions	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.	From baseline to 12 months	No
Secondary	Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions	Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.	From baseline to 12 months	No