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

The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients Taking Low-dose Aspirin, A Pilot Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01397240

Acronym

AL-PA

Enrollment

Registered

2011-07-19

Start date

2011-07-31

Completion date

2013-06-30

Last updated

2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Taking Low-dose Aspirin

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.

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

Interventions

DRUGAlbis Tab

2 Tab, twice a day, 12 weeks

DRUGPlacebo

2 Tab, twice a day, 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence rate of Gastric Ulcer	2 years

Secondary

Measure	Time frame
Incidence rate of gastiritis	2 years

Countries

South Korea

Contacts

Primary ContactHyo Jin Park

hjpark21@yuhs.ac82-2-2019-3318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026