A parallel group study to demonstrate the safety and efficacy of two molecules i.e. ferrous bisglycinate chelate and ferrous ascorbate in female patients with iron deficiency anaemia".

Phase 3

Completed

• Conditions: Iron Deficiency Anaemia

• Registration Number: CTRI/2011/11/002109
• Lead Sponsor: GlaxoSmithKline Pharmaceuticals LtdAddress AB Road Worli Mumbai

Brief Summary

Study design and patient population: This will be a multicentre, randomized, laboratory-blinded, parallel- group study. It is projected that the study will randomize 270 women (90 subjects in each treatment arm) with iron deficiency anaemia (Hb 8-9gm/dl + serum transferrin saturation <15%) to either Ferronine (ferrous bisglycinate chelate) 1 or 2 tablets/day, or Orofer XT (ferrous ascorbate) 1 tablet/day for 8 weeks. At fortnightly visits, blood will be collected for Hb (to evaluate efficacy), adverse events will be documented (to evaluate tolerability), the investigational drugs will be dispensed and reasons for non compliance will be recorded. Study endpoints: The primary endpoint is defined as the rise of Hb from baseline after 8 weeks of treatment in each ferrous bisglycinate chelate group (1 tablet/day and 2 tablets/day). The secondary endpoints include the difference in the average change in Hb, difference in the rate of rise of Hb, difference in the proportion of patients who achieve a target Hb &#8805;11gm/dl and difference in the % incidence of gastrointestinal side effects during 8 week therapy with 2 dosing regimens of ferrous bisglycinate chelate (1 tablet/day and 2 tablets/day) and ferrous ascorbate 1 tablet/day. Target of 270 Subject completed on 23/12/2010.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-15
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• Signed and dated written informed consent is obtained prior to participation.
• Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active.
• Non use of any iron supplement for 3 months prior to enrolment to the study.
• Presence of iron deficiency anaemia: low haemoglobin (Hb 6-9 gm/dl) + low serum ferritin (15 μg/l).
• No occult blood in stool.
• Able to comply with the requirements of the protocol.
• Subjects should have a valid telephone contact.

Exclusion Criteria

• Pregnancy (confirmed by urine dipstick method) Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception.
• Lactating women.
• Medical history of current hematological disorders other than iron deficiency anaemia (e.g. aplastic anaemia, megaloblastic anaemia, sideroblastic anaemia, pernicious anaemia, thalassemia, sickle cell anaemia, etc.).
• Medical history of thyroid dysfunction.
• Medical history of chronic renal disease.
• Medical history of malabsorption syndrome, haemochromatosis and haemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy.
• Inability to withhold prohibited medication.
• Clinically significant abnormality in laboratory reports and/or ECG.
• Medical history of hepatitis B, hepatitis C and/or exposure to HIV.
• Serious, uncontrolled disease (other than thyroid dysfunction and chronic renal disease) including serious psychological disorders likely to interfere with the study and/or likely to cause death within the study period.
• Participation in another clinical trial in the last 8 weeks before entry to Visit 0.
• Evidence of alcohol or drug abuse, that may, in the opinion of the investigator interfere with study compliance or prevent understanding of the objectives, investigational procedures or possible consequences of the study.
• Known or suspected hypersensitivity to iron or any of the components of Ferronine or Orofer XT tablets.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Hemoglobin Rise in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).	every 2 Weeks upto 8 weeks

Secondary Outcome Measures

Name	Time	Method
1. Haemoglobin at 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily).2. Haemoglobin at 2 weeks, 4 weeks, 6 weeks and 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily).3. The proportion of patients who achieve a target Hb ≥11gm/dl at 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 tablet and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily).	8 Weeks
2.To compare the average rate of rise of haemoglobin during 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.	8 weeks
3.To compare the proportion of patients who achieve a target Hb ≥ 12gm/dl after 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.	8 weeks
4.To compare the % incidence of gastrointestinal side effects during 8 weeks treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.	8 weeks

Trial Locations

Locations (7)

Girish Group of Hospitals; 🇮🇳 Surat, GUJARAT, India

Infertility Centre, Nagpur Test tube baby Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Jehangir Clinical Development Centre; 🇮🇳 Pune, MAHARASHTRA, India

M.V. Hospital & Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Prakruti Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Rajajipuram Hospital & Maternity Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

SRMS Institute of Medical Sciences; 🇮🇳 Bareilly, UTTAR PRADESH, India

Girish Group of Hospitals

🇮🇳Surat, GUJARAT, India

Dr Rajan Shah

Principal investigator

09825198915

drrajan_1979@yahoo.co.in