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Trial record 20 of 514 for:    aspirin AND prevention

The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients (AL-PA)

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ClinicalTrials.gov Identifier: NCT01397240
Recruitment Status : Unknown
Verified July 2011 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Recruiting
First Posted : July 19, 2011
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief Summary:
The purpose of this study is to research the safety and efficacy of Albis® for the prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.

Condition or disease Intervention/treatment Phase
Patients Taking Low-dose Aspirin Drug: Albis Tab Drug: Placebo Phase 4

Detailed Description:
The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients taking Low-dose Aspirin, A pilot study Double-Blind, Placebo-Controlled, Randomized, Multicenter, Parallel, Prospective study

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients Taking Low-dose Aspirin, A Pilot Study
Study Start Date : July 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Albis
Drug: Albis Tab 2 tab, twice a day
Drug: Albis Tab
2 Tab, twice a day, 12 weeks

Placebo Comparator: Placebo
Placebo 2 tab, twice a day
Drug: Placebo
2 Tab, twice a day, 12 weeks




Primary Outcome Measures :
  1. Incidence rate of Gastric Ulcer [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Incidence rate of gastiritis [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 20 to 80 years
  • Subjects identified with at least one of the following diagnosis (Angina, Myocardial Infarction(Old), Cerebrovascular Disease, Peripheral Vascular Disease, Diabetes, Hypertension, Hypercholeseterolemia, Obesity) who are required to take a low dose of Aspirin (100mg/day) for more than 12 weeks.

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
  • Peptic ulcer or Reflux oesophagitis
  • hemostatic disorder or coagulation disorder
  • Known allergy or hypersensitivity to the study medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397240


Contacts
Contact: Hyo Jin Park 82-2-2019-3318 hjpark21@yuhs.ac

Locations
Korea, Republic of
Gangnam severance Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Hyo Jin Park Gangnam Severance Hospital

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01397240     History of Changes
Other Study ID Numbers: DW_ABS002P
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: July 2011

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics