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Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

NCT01382901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-02-20

Study results available
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Summary

The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)

Conditions

  • Restless Legs Syndrome (RLS)

Interventions

DRUG

Ferric Carboxymaltose (FCM)

DRUG

Placebo

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-07-31
Completion
2007-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382901 on ClinicalTrials.gov