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

Primary Purpose

Iron Deficiency Anemia

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

V0355

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug

Arm Description

Outcomes

Primary Outcome Measures

Maximum Plasma concentration (Cmax)

Time to Maximum Concentration (Tmax)

Area under the iron plasma concentration curve (AUC)

Secondary Outcome Measures

Tolerability of single administration

Tolerability by evaluating the number of subjects with emergent adverse events

Full Information

NCT ID

NCT02518568

First Posted

August 4, 2015

Last Updated

September 27, 2016

Sponsor

Pierre Fabre Medicament

1. Study Identification

Unique Protocol Identification Number

NCT02518568

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Study Start Date

August 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (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 after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 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

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

V0355

Intervention Description

Oral administration (2 tablets)

Primary Outcome Measure Information:

Title

Maximum Plasma concentration (Cmax)

Time Frame

up to 24 hours after oral administration

Title

Time to Maximum Concentration (Tmax)

Time Frame

up to 24 hours after oral administration

Title

Area under the iron plasma concentration curve (AUC)

Time Frame

up to 24 hours after oral administration

Secondary Outcome Measure Information:

Title

Tolerability of single administration

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

Eligibility 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.

Facility Information:

City

Sofia

Country

Bulgaria

City

Iasi

Country

Romania

12. IPD Sharing Statement

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

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