A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
NCT ID: NCT01425463
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2011-03-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ferrous (II) Glycine Sulphate Complex
Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Ferrous (II) Glycine Sulphate Complex
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.
Placebo to Polyferose
Administered orally with water.
Polyferose
Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose
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 Complex
Administered orally with water.
Interventions
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Ferrous (II) Glycine Sulphate Complex
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.
Polyferose
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 Complex
Administered orally with water.
Placebo to Polyferose
Administered orally with water.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* With a history of Thalassemia or Sickle Cell Anemia
* With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
16 Years
75 Years
ALL
No
Sponsors
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Sanol GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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15
Changsha, , China
16
Changsha, , China
1
Fuzhou, , China
10
Guangzhou, , China
5
Hangzhou, , China
6
Hangzhou, , China
7
Jinan, , China
8
Jinan, , China
13
Shanxi, , China
14
Shanxi, , China
12
Shenyang, , China
2
Tianjin, , China
17
Wenzhou, , China
4
Wuxi, , China
9
Xi'an, , China
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-004380-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0986
Identifier Type: -
Identifier Source: org_study_id
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