Status:
COMPLETED
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Lead Sponsor:
Sanol GmbH
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief 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
- An iron deficiency anemia patient with Serum Ferritin \< 12 ng/mL, serum Hb-values \>60 and \< 120 g/L in males, \< 110 g/L in females
Exclusion
- With any Mal-absorption Syndrome
- With a history of Thalassemia or Sickle Cell Anemia
- With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01425463
Start Date
March 1 2011
End Date
November 1 2013
Last Update
June 1 2015
Active Locations (15)
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1
15
Changsha, China
2
16
Changsha, China
3
1
Fuzhou, China
4
10
Guangzhou, China