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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02518568
• Date of registration: 04/08/2015
• Prospective Registration: No
• Primary sponsor: Pierre Fabre Medicament
• Public title: Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia
• Scientific 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.
• Date of first enrolment: August 2015
• Target sample size: 29
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02518568
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Bulgaria, Romania

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Iron Deficiency Anemia

Intervention(s)

Drug: V0355

Primary Outcome(s)

Area under the iron plasma concentration curve (AUC) [Time Frame: up to 24 hours after oral administration]

Time to Maximum Concentration (Tmax) [Time Frame: up to 24 hours after oral administration]

Maximum Plasma concentration (Cmax) [Time Frame: up to 24 hours after oral administration]

Secondary Outcome(s)

Tolerability of single administration [Time Frame: Up to 24 hours]

Secondary ID(s)

V00355 CP 1 02

2015-000544-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors