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Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)

NCT01352221 · 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 Crohn's Disease (CD).

Conditions

Interventions

DRUG

ST10

30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase

DRUG

Placebo oral capsule

Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase

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 NCT01352221 on ClinicalTrials.gov