Status:
COMPLETED
Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
Lead Sponsor:
JW Pharmaceutical
Conditions:
Iron Deficiency Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
Eligibility Criteria
Inclusion
- 30\~32nd weeks pregnant women aged over 18 years
- Women who have Hb level of more than 10.0g/dL a week before study initiation
- Patients who agree to participate in this study in writing
Exclusion
- Patients who have participated in another clinical study in recent 3 months
- Patients who are prone to acute hemorrhage during pregnancy
- Patients who have shown intolerance to iron therapy
- Hemolytic anemia, hemoglobinopathies (thalassemia, sickle cell)
- Bleeding tendency, hypersplenism
- Chronic heart failure, Class II-IV heart disease, uncontrolled arterial hypertension (DBP ≥ 115mmHg), deep vein thrombosis, thrombocytosis, chronic renal disease
- Severe renal failure patients (2.5 times or more higher plasma creatinine level than high limit of normal state)
- Patients with severe liver dysfunction (2.5 times or more higher AST or ALT than high limit of normal state)
- Patients with doubled or more CK level than high limit of normal state
- Patients who are regarded as ineligible for this study by investigator
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00802139
Start Date
February 1 2008
End Date
October 1 2010
Last Update
March 30 2012
Active Locations (3)
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1
Chonnam National Universitiy Hospital
Kwangju, South Korea
2
Asan Hospital
Seoul, South Korea
3
Catholic University of Korea Kangnam St. Mary's Hospital
Seoul, South Korea