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CTRI Number  CTRI/2011/11/002109 [Registered on: 08/11/2011] Trial Registered Retrospectively
Last Modified On: 08/11/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   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". 
Scientific Title of Study   A multicentre, randomized, laboratory-blinded, parallel-group study to demonstrate the efficacy and tolerability of ferrous bisglycinate chelate in iron deficiency anaemia and to compare these with those of ferrous ascorbate. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
JC2010/00011/01  Protocol Number 
OTH114204  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonia Agarwal 
Designation  Principal Investigator  
Affiliation  Consultant  
Address  Ethika Clinical Research Centre
Prakruti Hospital, Siddeshwar Arcade,
Thane
MAHARASHTRA
400605
India 
Phone  9122-253-86760  
Fax  9122-253-86760  
Email  soniyapagarwal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Liesel DSilva 
Designation  Senior Medical Advisor  
Affiliation  Medical Affairs Department  
Address  252, Dr. A B Road
Worli
Mumbai
MAHARASHTRA
400030
India 
Phone  02224959552  
Fax  02224947415  
Email  liesel.c.dsilva@gsk.com  
 
Details of Contact Person
Public Query  
Name  Rodabeh Vania  
Designation  Clinical Research Associate  
Affiliation  GlaxoSmithKline  
Address  252, Dr. A B Raod, Worli
GlaxoSmithKline Pharmaceuticals Limited
Mumbai
MAHARASHTRA
400030
India 
Phone  02224959394  
Fax  02224947415  
Email  rodabeh.f.vania@gsk.com  
 
Source of Monetary or Material Support  
GlaxoSmithKline Pharmaceuticals Ltd. 252, A B Road, Worli, Mumbai 400030 
 
Primary Sponsor  
Name  GlaxoSmithKline Pharmaceuticals LtdAddress AB Road Worli Mumbai  
Address  GlaxoSmithKline Pharmaceuticals Ltd. 252, Dr. A.B. Road, Worli, Mumbai - 400 030 India.  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajan Shah  Girish Group of Hospitals  Research Department.G Tower Shankeshwar Complex,,Majura Gate, Ring Road-395002
Surat
GUJARAT 		 09825198915
02613072879
drrajan_1979@yahoo.co.in 
Dr Sadhana Patwardhan  Infertility Centre, Nagpur Test tube baby Centre  Infertility Centre,Research Room,First Floor, J P Chambers 2,Madhav Nagar,South Ambazari Road-440022
Nagpur
MAHARASHTRA 		 07122234428
07122234428
drsadhanapatwardhan@yahoo.com 
Dr Mahesh Kagali  Jehangir Clinical Development Centre  Jehangir Clinical Research Department. First Floor. Jehangir Hospital, 32, Sassoon Road, ,-411001
Pune
MAHARASHTRA 		 0992344476
02026059319
shashi@jcdc.co.in 
Dr Sandeep Kumar Gupta  M.V. Hospital & Research Centre  Department of Clinical Research. 314/30 Mirza Mandi, Chowk, ,-226003
Lucknow
UTTAR PRADESH 		 09336077839
05224016051
sandeepkumar.gupta@rediffmail.com 
Dr Soniya Agarwal  Prakruti Hospital  Ethika Clinical Research Centre,First Floor.Siddeshwar Arcade,Opp. Manisha Nagar, Gate No: 01, Kalwa -400605
Thane
MAHARASHTRA 		 02225386760
02225386750
soniyapagarwal@yahoo.com 
Dr Tuhina Shukla  Rajajipuram Hospital & Maternity Centre  Ground floor.Research Department.E-1075, Rajajipuram,-226017
Lucknow
UTTAR PRADESH 		 05224011392
05224011392
dr.tshukla@rediffmail.com 
Dr Lalit Singh  SRMS Institute of Medical Sciences  Medicine Department. Bareilly Nainital Road,,Bhojipura,-243202
Bareilly
UTTAR PRADESH 		 09415134959
05812582010
drlalits@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Bioethics Forum of Lucknow (Rajajipuram Hospital & Maternity Centre)  Approved 
Heart First Ethics Committee  Approved 
Hirabai Cowasji Jehangir Medical Research Institute & Jehangir Clinical Development Ethics Commitee  Approved 
IEC of M.V.Hospital & Research Centre  Approved 
Intersystem Biomedica Ethics Committee (Infertility Centre, Nagpur Test tube baby Centre)  Approved 
Intersystem Biomedica Ethics Committee (Prakruti Hospital)  Approved 
Intersystem Biomedica Ethics Committee (SRMS Institute of Medical Sciences)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Iron Deficiency Anaemia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ferronine  60 mg BD [twice daily] for 2 months 
Intervention  Ferronine  60 mg OD for 2 months 
Comparator Agent  Orofer XT  100 mg OD for 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  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.

Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator.

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.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean Hemoglobin Rise in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).  every 2 Weeks upto 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/10/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None till date  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 
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