Phase 3
N=256
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01425463 ↗Enrolled (actual)
256
Serious AEs
2.4%
Results posted
Nov 2014
Primary outcome: Primary: Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 — 31.47; 31.92 gramm per liter (g/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferrous (II) Glycine Sulphate Complex (Drug); Polyferose (Drug); Placebo to Ferrous (II) Glycine Sulphate Complex (Other); Placebo to Polyferose (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Sanol GmbH
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 |
31.47; 31.92 | — |
| SECONDARY Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 |
12.29; 12.79 | — |
| SECONDARY Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 |
20.37; 20.16 | — |
| SECONDARY Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 |
26.57; 28.33 | — |
| SECONDARY Percentage of Responders at Week 12 |
71.6; 80.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- An iron deficiency anemia patient with Serum Ferritin 60 and < 120 g/L in males, < 110 g/L in females
Exclusion Criteria
- With any Mal-absorption Syndrome
- With a history of Thalassemia or Sickle Cell Anemia
- With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
Data sourced from ClinicalTrials.gov (NCT01425463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.