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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01397240
First received: July 18, 2011
Last updated: January 8, 2012
Last verified: July 2011
  Purpose

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 Intervention Phase
Patients Taking Low-dose Aspirin
Drug: Albis Tab
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • Incidence rate of Gastric Ulcer [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence rate of gastiritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01397240     History of Changes
Other Study ID Numbers: DW_ABS002P
Study First Received: July 18, 2011
Last Updated: January 8, 2012
Health Authority: Korea: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014