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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004139-49-IT

Enrollment

300

Registered

2007-12-10

Start date

2008-02-05

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Code: V0355CP3A Pharmaceutical Form: Tablet INN or Proposed INN: Ferrous sulfate Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ambulatory female between 18 and 50 years. Haemoglobin level between 90 g/L and 120 g/L. Serum ferritin level =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate non-inferiority of V0355CP3A versus FERROGRAD on haemoglobin level restoration after 12-week treatment in iron deficiency anaemia. ; Secondary Objective: To assess the efficacy on: Iron stores restoration,patient?s anaemia related symptoms,patient's quality of life improvement. To evaluate the gastrointestinal and the global tolerability of the products. ; Primary end point(s): To assess the efficacy and tolerability of 12 weeks treatment with V0355CP3A as compared to FERROGRAD in the treatment of iron deficiency anaemia.	—

Measure

Time frame

Main Objective: To demonstrate non-inferiority of V0355CP3A versus FERROGRAD on haemoglobin level restoration after 12-week treatment in iron deficiency anaemia. ; Secondary Objective: To assess the efficacy on: Iron stores restoration,patient?s anaemia related symptoms,patient's quality of life improvement. To evaluate the gastrointestinal and the global tolerability of the products. ; Primary end point(s): To assess the efficacy and tolerability of 12 weeks treatment with V0355CP3A as compared to FERROGRAD in the treatment of iron deficiency anaemia.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026