Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01757119
First received: December 20, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia
Drug: Tardyferon 80 mg
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Pharmacokinetics of Serum Iron After Single Oral Administration of Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: Yes ]
    Tolerability by evaluating the number of subjects with emergent adverse events


Enrollment: 55
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Drug: Tardyferon 80 mg
Oral administration (2 tablets)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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: NCT01757119

Locations
Romania
Iasi, Romania
Timisoara, Romania, 300244
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01757119     History of Changes
Other Study ID Numbers: L00008 CP 1 01, 2012-002190-63
Study First Received: December 20, 2012
Last Updated: April 14, 2014
Health Authority: Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014