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A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects

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ClinicalTrials.gov Identifier: NCT01425463
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : November 6, 2014
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( Sanol GmbH )

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferrous (II) Glycine Sulphate Complex Drug: Polyferose Other: Placebo to Ferrous (II) Glycine Sulphate Complex Other: Placebo to Polyferose Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Other Name: Ferro Sanol Duodenal

Other: Placebo to Polyferose
Administered orally with water.

Active Comparator: Polyferose
Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Drug: 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.

Other Name: Nifirex

Other: Placebo to Ferrous (II) Glycine Sulphate Complex
Administered orally with water.




Primary Outcome Measures :
  1. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 [ Time Frame: From Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 [ Time Frame: From Baseline to Week 2 ]
  2. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 [ Time Frame: From Baseline to Week 4 ]
  3. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 [ Time Frame: From Baseline to Week 8 ]
  4. Percentage of Responders at Week 12 [ Time Frame: End of Treatment Period (Week 12) ]
    Responders are defined as having an increment of Hemoglobin (Hb) > 15 g/L and post-treatment Hb > 120 g/L (male) or > 110 g/L (female) at Visit 6 (Week 12).



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425463


Locations
China
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
Sponsors and Collaborators
Sanol GmbH
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Responsible Party: Sanol GmbH
ClinicalTrials.gov Identifier: NCT01425463     History of Changes
Other Study ID Numbers: SP0986
2014-004380-20 ( EudraCT Number )
First Posted: August 30, 2011    Key Record Dates
Results First Posted: November 6, 2014
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by UCB Pharma ( Sanol GmbH ):
Ferrous (II) Glycine Sulphate Complex
Polyferose
Ferro Sanol duodenal
Niferex
Iron Deficiency Anemia

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs