E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency anaemia in inflammatory bowel disease |
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E.1.1.1 | Medical condition in easily understood language |
Iron deficiency anaemia in patients who have also have inflammatory bowel disease such as Crohn's disease or ulcerative colitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002062 |
E.1.2 | Term | Anaemia iron deficiency |
E.1.2 | System Organ Class | 100000004851 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021972 |
E.1.2 | Term | Inflammatory bowel disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the feasibility of doing a larger clinical trial |
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E.2.2 | Secondary objectives of the trial |
Does low dose oral iron affect the stool bacterial population in IBD patients? Is a reduced dose oral iron safe and effective in correcting anaemia associated with IBD? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(i) Patient is willing to participate in the study and has signed the informed consent (ii) Patients aged 18-80 with Crohn’s disease or ulcerative colitis diagnosed by conventional clinical, radiological and histological criteria. (ii) Haemoglobin level 7-13 g/dL men, 7-12 g/dL women and evidence of iron deficiency as defined by ferritin <100 ug/l, normal B12 and folate, ferritin <200 ug/l but iron saturation <18% in the presence of anaemia and raised inflammtory markers
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E.4 | Principal exclusion criteria |
(i) Patients under 18 or unable to give informed consent. (ii) Patients with advanced liver disease. (iii) Patients with advanced renal disease. (iv) Previous intolerance of oral iron. (v) Patients with severe cardiovascular disease defined as previous unstable angina and or previous MI without intervention. (vi) Participation in other trials in the last 3 months. (vii) Serious inter-current infection or other clinically important active disease (including renal and hepatic disease) (viii) Pregnant, post partum (<3months) or breast feeding females (ix) Erythropoetin therapy. (x) Recent blood transfusion within 30 days. (xi) Recent iron infusion within 30 days. |
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E.5 End points |
E.5.1 | Primary end point(s) |
This is a pilot study. The primary outcome is to examine the feasibility of a larger randomised trial. Estimates of the variability of hamoglobin will be obtained which will inform the design of a future trial. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluable at the end of study |
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E.5.2 | Secondary end point(s) |
(i) Improvement in haemoglobin concentration from baseline to end of study and at week 4. (ii) Assessment of iron stores at weeks 4 and 8. (iii) Assessment of faecal calprotectin at weeks 4 and 8. (iv) Assessment of disease severity using standardised questionnaires at weeks 4 and 8. (v) Quality of life at weeks 4 and 8. (vi) Patient global assessment of symptom severity by visual analogue score at weeks 4 and 8 or early withdrawal. (vii) Patient assessment of fatigue at weeks 4 and 8 using IBD-F fatigue score. (viii) Patient assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance – will all be assessed at all visits. (ix) Changes in stool bacterial composition from baseline to end of study
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At defined time points and all analyses will be conducted as specified in the protocol |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study will be completed when the last subject has been enrolled and completes the study period. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |