CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 128 enrolled
Drug / intervention
ST10-021 +1 moredrug
Likely dose
ST10-021 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01340872
NCT01340872Phase 3Completed
CompareCT.gov

A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)

Shield Therapeutics·interventional·Posted Apr 25, 2011·Updated Oct 30, 2020

In Brief

A Phase 3 clinical trial evaluating ST10-021 and Placebo Comparator for Iron Deficiency Anaemia and 2 related conditions. Completed, enrolled 128 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anaemia, Inflammatory Bowel Disease, Ulcerative Colitis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 25, 2011
Enrollment StartAug 1, 2011
Primary CompletionOct 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.2 years ago

Interventions

ST10-021drug

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

Placebo Comparatordrug

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