Ferrous Sulphate Supplement (V0355) in Women With Iron De... | NCT02518568

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

NCT02518568

Sponsor

Pierre Fabre Medicament

Status

Terminated

Last Update Posted

Sep 28, 2016Estimated

Enrollment

29Actual

Phase

Phase 1

Conditions

Iron Deficiency Anemia

Interventions

V0355

Countries

Bulgaria
Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-000544-42	EudraCT Number

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2016

Last Update Posted Date

Sep 28, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Label	Type	Description	Intervention Names
Drug	Experimental		Drug: V0355

Name	Type	Description	Arm Group Labels	Other Names
V0355	Drug	Oral administration (2 tablets)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Plasma concentration (Cmax)		up to 24 hours after oral administration
Time to Maximum Concentration (Tmax)		up to 24 hours after oral administration
Area under the iron plasma concentration curve (AUC)		up to 24 hours after oral administration

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of single administration	Tolerability by evaluating the number of subjects with emergent adverse events	Up to 24 hours

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Sofia			Bulgaria