E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with IBD and chronic fatigue |
pazienti con fatica cronica e IBD |
|
E.1.1.1 | Medical condition in easily understood language |
patients with IBD and chronic fatigue |
pazienti con fatica cronica e IBD |
|
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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10017947 |
E.1.2 | Term | Gastrointestinal disorders |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 |
chronic fatigue remission (MFI-20 <13) |
remissione della fatica cronica (MFI-20 <13) |
|
E.2.2 | Secondary objectives of the trial |
Clinical response, defined as decrease in MFI-20 of at least 4 points, but with a score > 13 |
risposta della fatica cronica (diminuzione MFI-20 di ≥4 punti) evoluzione dell’ansia e depressione e cambiamento della qualita' di vita alla settimana 4, 12 e 24 dall’inizio della somministrazione di ferro o placebo mediante i questionari appositi |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Man and women, 18 years of age or older. - Female subjects must utilize a highly effective method of birth control throughout the study. - At least 12-month history of IBD. - Inactive Crohn’s disease or Ulcerative colitis (HB: <5, Mayo Clinical Score: ≤ 2) since at least 6 months - Chronic fatigue symptoms (Mfi-20 > 13). - Concurrent stable doses of 5-aminosalicylate, azathioprine, methotrexate or anti TNFα. - Iron deficiency: ferritin< 100 ng/ml or ferritin 100-300 ng/ml when transferring saturation (TSAT) < 20%. |
• Pazienti maschi e femmine, di eta' compresa tra i 18 e i 75 anni. • Tutte le donne in eta' fertile devono avere un test di gravidanza su siero negativo immediatamente prima dell’arruolamento • Diagnosi di RCU o MC da piu' di 12 mesi, confermata con esami endoscopici e/o di imaging. • Remissione clinica (HB<5 ; Mayo clinical score ≤2 ) da almeno 6 mesi. • Sintomi da fatica cronica (Mfi-20 > 13). • Carenza marziale: ferritina< 100 microg/l o < 300 microg/l se percentuale di saturazione transferrina < 20%. |
|
E.4 | Principal exclusion criteria |
- Known hypersensitivity to iron sucrose or to its excipients. - Pregnancy: women with childbearing potential must not become pregnant during the study. - Clinically active IBD and /or C-reactive protein >2.5. - Comorbidity possibly resulting in (additional) fatigue (e.g., kidney or adrenal insufficiency, autoimmune diseases, malignancy, depression, a recent viral infection, or psychotrauma psychic diseases, included depression. - Anaemia (Hb:< 12.5 in male and < 11.5 in female |
• Hb:< 12.5 negli uomini; < 11.5 nelle donne • Ipersensibilita` conosciuta al principio attivo o ad uno qualsiasi degli eccipienti. • Donne in gravidanza o in allattamento. • Malattia attiva clinicamente e/o PCR>2.5. • Insufficienza renale. • Insufficienza surrenale. • Malattie autoimmuni. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
chronic fatigue remission |
remissione della fatica cronica |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
chronic fatigue response |
risposta alla fatica cronica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.4 | Safety | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |