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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01425463
First received: August 26, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 2 [ Time Frame: From Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 4 [ Time Frame: From Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 8 [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Percentage of responders at Week 12 [ Time Frame: End of Treatment Period (Week 12) ] [ Designated as safety issue: No ]
    Responders are defined as having an increment of Hb > 15 g/l, or post-treatment Hb > 120 g/l (male) and > 110 g/l (female).


Enrollment: 247
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Sham 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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425463

Locations
China
15
Changsha, China
16
Changsha, China
1
Fuzhou, China
10
Guangzhou, China
5
Hangzhou, China
6
Hangzhou, China
8
Jinan, China
7
Jinan, China
14
Shanxi, China
13
Shanxi, China
12
Shenyang, China
2
Tianjin, China
17
Wenzhou, China
4
Wuxi, China
9
Xi'an, China
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01425463     History of Changes
Other Study ID Numbers: SP0986
Study First Received: August 26, 2011
Last Updated: June 16, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by UCB Pharma:
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014