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
This study is currently recruiting participants.
Verified April 2013 by UCB, Inc.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01425463
First received: August 26, 2011
Last updated: April 4, 2013
Last verified: April 2013
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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 |
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, Inc.:
Primary Outcome Measures:
- Change of hemoglobin (Hb) from baseline to 12 weeks after start of treatment(visit 6) [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change of hemoglobin (Hb) from baseline to 2 weeks after start of treatment (visit 3 ) [ Time Frame: From Baseline to 2 weeks ] [ Designated as safety issue: No ]
- Change of hemoglobin (Hb) from baseline to 4 weeks after start of treatment (visit 4 ) [ Time Frame: From Baseline to 4 weeks ] [ Designated as safety issue: No ]
- Change of hemoglobin (Hb) from baseline to 8 weeks after start of treatment (visit 5 ) [ Time Frame: From Baseline to 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Polyferose
Polyferose treatment with 150 mg, Bid, per day for 12 weeks plus placebo to Ferrous (II) Glycine Sulphate Complex.
|
Drug: Polyferose
Polyferose treatment with 150 mg, Bid, per day for 12 weeks plus placebo to Ferrous (II) Glycine Sulphate Complex
|
|
Experimental: Ferrous (II) Glycine Sulphate Complex
Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg, Tid, per day for 12 weeks plus placebo to Polyferose.
|
Drug: Ferrous (II) Glycine Sulphate Complex
Oral dose at 567.7 mg, Tid, per day for 12 weeks plus placebo to Polyferose
Other Name: Ferro Sanol Duodenal
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425463
Contacts
| Contact: UCB Clinical Trial Call Center | +1 877 822 9493 |
Locations
| China | |
| 15 | Recruiting |
| Changsha, China | |
| 1 | Recruiting |
| Fuzhou, China | |
| 10 | Recruiting |
| Guangzhou, China | |
| 5 | Recruiting |
| Hangzhou, China | |
| 6 | Recruiting |
| Hangzhou, China | |
| 7 | Recruiting |
| Jinan, China | |
| 8 | Recruiting |
| Jinan, China | |
| 3 | Recruiting |
| Shanghai, China | |
| 11 | Not yet recruiting |
| Shanghai, China | |
| 13 | Recruiting |
| Shanxi, China | |
| 14 | Recruiting |
| Shanxi, China | |
| 12 | Recruiting |
| Shenyang, China | |
| 2 | Recruiting |
| Tianjin, China | |
| 4 | Recruiting |
| Wuxi, China | |
| 9 | Recruiting |
| Xi'an, China | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01425463 History of Changes |
| Other Study ID Numbers: | SP0986 |
| Study First Received: | August 26, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by UCB, Inc.:
|
Ferro Sanol duodenal Niferex Iron deficiency anemia |
Additional relevant MeSH terms:
|
Anemia Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders |
Metabolic Diseases Glycine Glycine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013