Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LARAn open pilot study

• Conditions: Crohn Disease refractory diarrhoea; MedDRA version: 12.1Level: LLTClassification code 10066533Term: Diarrhea recurrent

• Registration Number: EUCTR2010-023347-14-BE
• Lead Sponsor: Gastroenterology CHC Liege

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-04
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified