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Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin

NCT ID: NCT00802139

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-10-31

Brief Summary

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multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study

Detailed Description

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Conditions

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Iron Deficiency Anemia

Keywords

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iron deficiency anemia pregnant women with iron deficiency anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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venoferrum group

Group Type EXPERIMENTAL

venoferrum(iron sucrose)

Intervention Type DRUG

administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.

Bolgre group

Group Type ACTIVE_COMPARATOR

Bolgre (Iron acetyl-transferase)

Intervention Type DRUG

Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks

Interventions

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venoferrum(iron sucrose)

administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.

Intervention Type DRUG

Bolgre (Iron acetyl-transferase)

Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim AM, ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan hospital OB/Gyn unit

Locations

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Chonnam National Universitiy Hospital

Kwangju, , South Korea

Site Status

Asan Hospital

Seoul, , South Korea

Site Status

Catholic University of Korea Kangnam St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CWP-VNF-402

Identifier Type: -

Identifier Source: org_study_id