NCT01397240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 10, 2012

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

July 18, 2011

Last Update Submit

January 8, 2012

Conditions

Patients Taking Low-dose Aspirin

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of Gastric Ulcer

    2 years

Secondary Outcomes (1)

  • Incidence rate of gastiritis

    2 years

Study Arms (2)

Albis

EXPERIMENTAL

Drug: Albis Tab 2 tab, twice a day

Drug: Albis Tab

Placebo

PLACEBO COMPARATOR

Placebo 2 tab, twice a day

Drug: Placebo

Interventions

Albis TabDRUG

2 Tab, twice a day, 12 weeks

Albis
PlaceboDRUG

2 Tab, twice a day, 12 weeks

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Hyo Jin Park

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo Jin Park

CONTACT

82-2-2019-3318hjpark21@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2013

Last Updated

January 10, 2012

Record last verified: 2011-07

Locations

KR(1)