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Trial record 1 of 1 for:    467-713
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Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02099708
First received: March 26, 2014
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
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)

Condition Intervention
Gastric or Duodenal Ulcers Drug: Lansoprazole

Study Type: Observational
Study Design: 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 Non-steroidal Anti-inflammatory Drugs

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome 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 Outcome 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.


Enrollment: 3502
Study Start Date: October 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lansoprazole 15 mg
Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
Drug: Lansoprazole
Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg
Other Name: Takepron Capsules 15 mg, Takepron Orally Disintegrating (OD) Tablets 15 mg

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099708

Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02099708     History of Changes
Other Study ID Numbers: 467-713
JapicCTI-142418 ( Registry Identifier: Japic CTI )
JapicCTI-R150705 ( Registry Identifier: JapicCTI )
Study First Received: March 26, 2014
Results First Received: August 6, 2015
Last Updated: September 23, 2016

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Ulcer
Recurrence
Duodenal Ulcer
Pathologic Processes
Disease Attributes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents
Lansoprazole
Dexlansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 26, 2017