Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

• ClinicalTrials.gov Identifier: NCT02099682
• Recruitment Status: Completed
• First Posted: March 31, 2014
• Results First Posted: June 25, 2015
• Last Update Posted: November 4, 2016
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

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

Condition or disease	Intervention/treatment
Gastric or Duodenal Ulcers	Drug: Lansoprazole

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 low-dose aspirin.

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Study Design

• Study Type: Observational
• Actual Enrollment: 3366 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Low-dose Aspirin
• Study Start Date: August 2010
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
Lansoprazole 15 mg; Lansoprazole 15 mg orally once daily	Drug: Lansoprazole; Lansoprazole Capsules 15/ OD Tablets; Other Name: Takepron Capsules 15/ OD Tablets

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Presence or Absence of Endoscopic Examinations [ Time Frame: From baseline to 12 months ]
   Summary of data on the presence or absence of endoscopic examinations.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Gastric or duodenal ulcers

Criteria

Inclusion Criteria:

• (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin 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

Contacts and Locations

Sponsors and Collaborators

Takeda

Investigators

• Study Chair: Postmarketing Group Manager; Takeda

More Information

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02099682
• Other Study ID Numbers: 467-712; JapicCTI-142414 ( Registry Identifier: JapicCTI ); JapicCTI-R150735 ( Registry Identifier: JapicCTI )
• First Posted: March 31, 2014
• Results First Posted: June 25, 2015
• Last Update Posted: November 4, 2016
• Last Verified: September 2016

Keywords provided by Takeda:

Pharmacological therapy

Additional relevant MeSH terms:

Duodenal Ulcer; Ulcer; Recurrence; Pathologic Processes; Disease Attributes; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Lansoprazole; Dexlansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action