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Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)

NCT01340872 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-10-30

Study results available
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Summary

The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).

Conditions

Interventions

DRUG

ST10-021

30 mg capsules to be taken orally twice a day for 12 weeks

DRUG

Placebo Comparator

Matching sugar pill to be taken orally twice a day for 12 weeks

Sponsors & Collaborators

  • Shield Therapeutics

    lead INDUSTRY

Principal Investigators

  • Nicholas Mallard, PhD · Shield Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-10-31
Completion
2014-10-31

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Entities

Diseases

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 NCT01340872 on ClinicalTrials.gov