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Trial record 1 of 1 for:    NCT01425463
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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 )

Tracking Information
First Submitted Date  ICMJE August 26, 2011
First Posted Date  ICMJE August 30, 2011
Results First Submitted Date  ICMJE October 30, 2014
Results First Posted Date  ICMJE November 6, 2014
Last Update Posted Date June 1, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 [ Time Frame: From Baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
Change of hemoglobin (Hb) from baseline to 12 weeks after start of treatment(visit 6) [ Time Frame: From Baseline to Week 12 ]
Change History Complete list of historical versions of study NCT01425463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2015)
  • Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 [ Time Frame: From Baseline to Week 2 ]
  • Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 [ Time Frame: From Baseline to Week 4 ]
  • Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 [ Time Frame: From Baseline to Week 8 ]
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
  • Change of hemoglobin (Hb) from baseline to 2 weeks after start of treatment (visit 3 ) [ Time Frame: From Baseline to 2 weeks ]
  • Change of hemoglobin (Hb) from baseline to 4 weeks after start of treatment (visit 4 ) [ Time Frame: From Baseline to 4 weeks ]
  • Change of hemoglobin (Hb) from baseline to 8 weeks after start of treatment (visit 5 ) [ Time Frame: From Baseline to 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • 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
  • 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.
  • Other: Placebo to Polyferose
    Administered orally with water.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Ferrous (II) Glycine Sulphate Complex
    • Other: Placebo to Polyferose
  • Active Comparator: Polyferose
    Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
    Interventions:
    • Drug: Polyferose
    • Other: Placebo to Ferrous (II) Glycine Sulphate Complex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2014)
256
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2011)
240
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01425463
Other Study ID Numbers  ICMJE SP0986
2014-004380-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( Sanol GmbH )
Study Sponsor  ICMJE Sanol GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP