Haematopoiesis Clinical Trial
Official title:
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.
| Verified date | September 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Iron deficiency anaemia (Haemoglobin, Hb < 12gm/dl) is one of India's major public health problems particularly in women. Effective control of iron deficiency anaemia decreases the incidence of fatigue, bodyache, headache, lack of concentration and menstrual complications. Iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is also a well tolerated therapy. Use of ferrous bisglycinate chelate one tablet daily as a nutritional supplement is well established in India. For treatment of iron deficiency anaemia, some women may need 1 tablet/day, while some may need 2 tablets/day. In India, ferrous ascorbate, 1 tablet daily is a widely accepted form of treatment for iron deficiency anaemia. The primary purpose of this study is to demonstrate the efficacy and tolerability profile of ferrous bisglycinate chelate to support the registration of this product as a 'drug' in India. Comparative data between ferrous bisglycinate chelate and ferrous ascorbate will also augment our existing knowledge, which will further support appropriate use of ferrous bisglycinate chelate for the treatment of iron deficiency anaemia. 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 6-9 gm/dl + serum Ferritin <15 μg/l) to either ferrous bisglycinate chelate 1 or 2 tablets/day, or 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 ≥12gm/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.
| Status | Completed |
| Enrollment | 271 |
| Est. completion date | February 18, 2011 |
| Est. primary completion date | February 18, 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria Subjects eligible for enrolment to the study must meet all of the following criteria: 1. Signed and dated written informed consent is obtained prior to participation. 2. Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active. 3. Non use of any iron supplement for 3 months prior to enrolment to the study. 4. Presence of iron deficiency anaemia: low haemoglobin (Hb 6-9 gm/dl) + low serum ferritin (<15 µg/l). 5. No occult blood in stool. 6. Able to comply with the requirements of the protocol. 7. Subjects should have a valid telephone contact. Exclusion Criteria Subjects meeting any of the following criteria must not be enrolled to the study: 1. Pregnancy (confirmed by urine dipstick method) 2. Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception. 3. Lactating women. 4. 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.). 5. Medical history of thyroid dysfunction. 6. Medical history of chronic renal disease. 7. Medical history of malabsorption syndrome, haemochromatosis and haemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy. 8. Inability to withhold prohibited medication. 9. Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator. 10. Clinically significant abnormality in laboratory reports and/or ECG. 11. Medical history of hepatitis B, hepatitis C and/or exposure to HIV. 12. 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. 13. Participation in another clinical trial in the last 8 weeks before entry to Visit 0. 14. 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. 15. Known or suspected hypersensitivity to iron or any of the components of ferrous bisglycinate chelate or ferrous ascorbate tablets. |
| Country | Name | City | State |
|---|---|---|---|
| India | GSK Investigational Site | Bhojipura, Bareilly | |
| India | GSK Investigational Site | Lucknow | |
| India | GSK Investigational Site | Lucknow | |
| India | GSK Investigational Site | Nagpur | |
| India | GSK Investigational Site | Pune | |
| India | GSK Investigational Site | Surat | |
| India | GSK Investigational Site | Thane,Mumbai |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily) | At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline and Week 8 | |
| Secondary | Mean Change in Hb From Baseline to 8 Weeks | At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. | Baseline to Week 8 | |
| Secondary | Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment | At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented. | Up to Week 8 | |
| Secondary | Mean Change in Hb During 8 Weeks Therapy | At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented. | Up to Week 8 | |
| Secondary | Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate | The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence. | Up to Week 8 |