The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients (AL-PA)
This study is currently recruiting participants.
Verified July 2011 by Daewoong Pharmaceutical Co. LTD.
Sponsor:
Daewoong Pharmaceutical Co. LTD.
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
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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
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 May 19, 2013