E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn Disease refractory diarrhoea |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066533 |
E.1.2 | Term | Diarrhea recurrent |
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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 |
The aim of this study is to assess the safety and efficacy of the somatostatin analogue, octreotide, in Crohn Disease (CD) refractory diarrhoea, in addition to other CD treatments, through an open pilot study. |
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E.2.2 | Secondary objectives of the trial |
To evaluate : - the safety of octreotide in CD by the recording of all SAEs - the effect of octreotide on the mean number of smooth or liquid stools after octreotide LAR - the effect of octreotide on the total number of bowel movements per day - the effect of octreotide on the activity of CD by measuring the Harvey-Bradschaw Index before and after treatment - the effect of octreotide on the systemic inflammatory reaction - the effect of octreotide on gastrointestinal tract inflammatory reaction - the effect of octreotide on health related quality of life - To assess the number of patients responding to octreotide. - To analyse possible parameters associated with a positive response to octreotide
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with certain CD according to Lennard-Jones criteria - Patients aged 18 or older (≥18 years) - Persisting diarrhoea, characterized by at least a mean of 5 smooth of liquid stools per day (mean of the number of stools over a one week period), despite either a normal CRP or an optimized specific treatment of CD including immunosuppressive treatment and/or infliximab - Diarrhoea refractory to loperamide and/or cholestyramine and requiring additional treatment with octreotide (Intention to treat the patient with octreotide) - For patients after a related surgical intervention, operation must be performed for a minimum of 6 months before inclusion in the trial - Written informed consent given
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E.4 | Principal exclusion criteria |
- Known allergy or intolerance to octreotide. - Diarrhoea due to small bowel microbial proliferation (infection). - Diarrhoea due to lactose intolerance - Diarrhoea due to irradiation - Diarrhoea due to chemotherapy - Diarrhoea due to neoplasia - Diarrhoea due to ischemia - Immediate need for surgery - Significant dehydration with the need for IV saline infusion - Severe malnutrition with a BMI <16 and the need for enteral or parenteral nutrition - Harvey-Bradschaw Index > 13 or with subscore for pain or general wellbeing > 2
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the effect of subcutaneous octreotide 100 microg tid for 3 days followed by one intramuscular injection of octreotide LAR on the diarrhoea associated with CD. Criteria of judgement: number of smooth or liquid stools per day between 22 and 28 days after octreotide LAR IM injection |
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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) | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | Information not present in EudraCT |
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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Last visit of last patient included |
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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 | 11 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 11 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 31 |