CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 256 enrolled
Drug / intervention
Ferrous (II) Glycine Sulphate Complex +3 moredrug
Likely dose
Ferrous (II) Glycine Sulphate Complex 567.7 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/NCT01425463
NCT01425463Phase 3Completed
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A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized and Multi-center Trial to Investigate Efficacy and Safety in Subjects With Iron Deficiency Anemia for Ferrous (II) Glycine Sulphate Complex Versus Polyferose Capsules Therapy

Sanol GmbH·interventional·Posted Aug 30, 2011·Updated Jun 1, 2015

In Brief

A Phase 3 clinical trial evaluating Ferrous (II) Glycine Sulphate Complex, Polyferose, and 2 other interventions for Iron Deficiency Anemia. Completed, enrolled 256 participants across 15 sites.

Detailed Summary

To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2011
Enrollment StartMar 1, 2011
Primary CompletionOct 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.8 years ago

Interventions

Ferrous (II) Glycine Sulphate Complexdrug

Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water.

Polyferosedrug

Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water.

Placebo to Ferrous (II) Glycine Sulphate Complexother

Administered orally with water.

Placebo to Polyferoseother

Administered orally with water.