Efficacy and tolerability of 12-weeks oral treatment with V0355CP3A versus Ferrograd, in iron deficiency anaemia. Multicenter, randomised, open-label trial. - ND

Phase 1

• Conditions: Iron deficiency anaemia.; MedDRA version: 6.1 Level: PT Classification code 10022972

• Registration Number: EUCTR2007-004139-49-IT
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-10
• Study Completion: 2009-03-31
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

Ambulatory female between 18 and 50 years. Haemoglobin level between 90 g/L and 120 g/L. Serum ferritin level < 30 µg/L). Willing to participate. Able to understand the protocol, to comply with its requirements and to attend to visits. Have given their written informed consent to participate in the study;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For women with childbearing potential:
o not using effective contraception (oral contraceptives, intrauterine device, tubal
ligation or other efficient procedures ),
o pregnant, breast feeding or likely to become pregnant during the time of the study
o positive urinary pregnancy test.
Anaemia related to other causes than iron deficiency.
Inflammatory bowel disease or any digestive disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified