Crohn Disease refractory diarrhoea MedDRA version: 12.1 Level: LLT Classification code 10066533 Term: Diarrhea recurrent
Conditions
Interventions
Trade Name: Sandostatine
Product Name: sandostatine
Pharmaceutical Form: Injection*
Trade Name: Sandostatine
Product Name: sandostatine
Pharmaceutical Form: Injection*
Sponsors
Gastroenterology CHC Liege
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 13 or with subscore for pain or general wellbeing > 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;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 | — |
Countries
Belgium
Outcome results
None listed