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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Patients Taking Low-dose Aspirin

Treatments: Drug: Placebo; Drug: Albis Tab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397240

DW_ABS002P

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Albis

Experimental group

Description:

Drug: Albis Tab 2 tab, twice a day

Treatment:

Drug: Albis Tab

Placebo

Placebo Comparator group

Description:

Placebo 2 tab, twice a day

Treatment:

Drug: Placebo