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Trial record 44 of 1664 for:    ( Map: Bulgaria )

Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia

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ClinicalTrials.gov Identifier: NCT02518568
Recruitment Status : Terminated
First Posted : August 10, 2015
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Brief Summary:
The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: V0355 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.
Study Start Date : August 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Drug Drug: V0355
Oral administration (2 tablets)



Primary Outcome Measures :
  1. Maximum Plasma concentration (Cmax) [ Time Frame: up to 24 hours after oral administration ]
  2. Time to Maximum Concentration (Tmax) [ Time Frame: up to 24 hours after oral administration ]
  3. Area under the iron plasma concentration curve (AUC) [ Time Frame: up to 24 hours after oral administration ]

Secondary Outcome Measures :
  1. Tolerability of single administration [ Time Frame: Up to 24 hours ]
    Tolerability by evaluating the number of subjects with emergent adverse events



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18-45 years inclusive 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

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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518568


Locations
Bulgaria
Sofia, Bulgaria
Romania
Iasi, Romania
Sponsors and Collaborators
Pierre Fabre Medicament

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02518568     History of Changes
Other Study ID Numbers: V00355 CP 1 02
2015-000544-42 ( EudraCT Number )
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

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