NCT00396292

Brief Summary

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

December 10, 2013

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

November 2, 2006

Results QC Date

October 15, 2013

Last Update Submit

January 22, 2018

Conditions

Anemia

Keywords

AnemiapostpartumPostpartum anemia

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin

    anytime between baseline and the end of study or time to intervention

Study Arms (2)

VIT-45

EXPERIMENTAL

A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

Drug: VIT-45

Oral iron tablets

ACTIVE COMPARATOR

325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

Drug: Oral iron tablets

Interventions

Oral iron tabletsDRUG

325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

Also known as: Ferrous Sulfate
Oral iron tablets
VIT-45DRUG

A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

VIT-45

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female Subjects able to give consent
  • Post partum patients
  • Baseline Hbg\< /= 10
  • Agree to practice birth control
  • Demonstrate willingness to comply with protocol restrictions

You may not qualify if:

  • Known hypersensitivity reaction to oral or IV iron (VIT-45)
  • Documented history of discontinuing oral iron
  • Significant bleeding
  • History of anemia other that iron deficiency anemia
  • Severe Psychiatric disorders
  • Active severe infection
  • Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
  • Known HIV antibody
  • Received investigational product within 30 days
  • Alcohol abuse
  • Hemochromatosis or other iron storage disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

Related Publications (3)

  • Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.

    RESULT

  • Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.

    RESULT

  • Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.

    PMID: 17666600DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Ironferrous sulfateferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Results Point of Contact

Title
Marc Tokars
Organization
Luitpold Pharmaceuticals, Inc.
mtokars@lpicrd.com
610-650-4200

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 6, 2006

Study Start

February 1, 2005

Primary Completion

November 1, 2005

Study Completion

February 1, 2006

Last Updated

February 5, 2018

Results First Posted

December 10, 2013

Record last verified: 2018-01

Locations

US(1)