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Trial record 74 of 310 for:    ASPIRIN AND low-dose aspirin

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

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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:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date March 26, 2014
First Posted Date March 31, 2014
Results First Submitted Date June 5, 2015
Results First Posted Date June 25, 2015
Last Update Posted Date November 4, 2016
Study Start Date August 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2015)
  • 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 Measures
 (submitted: March 26, 2014)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
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
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Gastric or duodenal ulcers
Condition Gastric or Duodenal Ulcers
Intervention Drug: Lansoprazole
Lansoprazole Capsules 15/ OD Tablets
Other Name: Takepron Capsules 15/ OD Tablets
Study Groups/Cohorts Lansoprazole 15 mg
Lansoprazole 15 mg orally once daily
Intervention: Drug: Lansoprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2014)
3366
Original Actual Enrollment Same as current
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02099682
Other Study ID Numbers 467-712
JapicCTI-142414 ( Registry Identifier: JapicCTI )
JapicCTI-R150735 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Chair: Postmarketing Group Manager Takeda
PRS Account Takeda
Verification Date September 2016