Back to resultsFerrous Sulphate Supplement in Women With Iron Deficiency Anaemia
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 1
Locations
Romania
Study Type
Interventional
Intervention
Tardyferon 80 mg
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia
Eligibility Criteria
Inclusion Criteria:
- Women 18-45 years old with iron deficiency anaemia
- haemoglobin level between 85 g/L and 105 g/L
- serum ferritin level < 15 µg/L
- D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
- Standard diet
Exclusion Criteria:
- - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
- Haemochromatosis or iron overload of secondary origin (blood transfusion),
- Long term treatment known to modify iron absorption,
- Gastro duodenal ulcer,
- Inflammatory bowel disease or any digestive disease which could modify iron absorption,
- Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,
- Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
- Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement by measuring Maximum Plasma concentration, Time of Maximum Concentration, Area under the iron plasma concentration curve.
Secondary Outcome Measures
Tolerability of single administration (reported adverse events)
Tolerability by evaluating the number of subjects with emergent adverse events
Full Information
NCT ID
NCT01757119
First Posted
December 20, 2012
Last Updated
April 14, 2014
Sponsor
Pierre Fabre Medicament
1. Study Identification
Unique Protocol Identification Number
NCT01757119
Brief Title
Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia
Official Title
Study of the Pharmacokinetics of Serum Iron After Single Oral Administration of Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tardyferon 80 mg
Intervention Description
Oral administration (2 tablets)
Primary Outcome Measure Information:
Title
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement
Description
Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement by measuring Maximum Plasma concentration, Time of Maximum Concentration, Area under the iron plasma concentration curve.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Tolerability of single administration (reported adverse events)
Description
Tolerability by evaluating the number of subjects with emergent adverse events
Time Frame
Up to 24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women 18-45 years old with iron deficiency anaemia
haemoglobin level between 85 g/L and 105 g/L
serum ferritin level < 15 µg/L
D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
Standard diet
Exclusion Criteria:
- Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
Haemochromatosis or iron overload of secondary origin (blood transfusion),
Long term treatment known to modify iron absorption,
Gastro duodenal ulcer,
Inflammatory bowel disease or any digestive disease which could modify iron absorption,
Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,
Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.
Facility Information:
City
Iasi
Country
Romania
City
Timisoara
ZIP/Postal Code
300244
Country
Romania
12. IPD Sharing Statement
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Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia
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