Conditions: Iron Deficiency Anaemia Inflammatory Bowel Disease Crohn's Disease
Keywords: iron deficiency anaemia inflammatory bowel disease Crohn's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active Crohn's Disease (CD).

Detailed description:
As no curative treatment is currently available for Crohn's Disease (CD), treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. As such, treatment of iron deficiency anaemia (IDA), a key symptom of the disease, is integral to the medical management of CD. Iron deficiency anaemia in CD is a chronically debilitating disorder which has a significant impact on the quality of life of affected subjects. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with CD suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in CD is typically oral ferrous products (OFP), however this is often not successful. Many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency. Common adverse effects of OFP include nausea, epigastric discomfort and constipation, all of which are dose-related and appear especially evident in subjects with CD.

As compared to oral ferrous iron, oral ferric iron can be administered with improved tolerability and the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced. In addition, the iron is retained in its chelated form if not absorbed and this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date provide preliminary evidence for the therapeutic potential of ST10-021 in patients with IDA in Inflammatory Bowel Disease, including CD.

The purpose of this study is to determine whether ST10-021 is safe and effective in the treatment of IDA in subjects with non-active CD. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used.

Arms:
arm 1: ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day arm 2: Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day

Interventions: intervention 1: ST10 intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: 30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase intervention 2: Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase

Protocol document: