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Register:	EUCTR
Last refreshed on:	17 February 2014
Main ID:	EUCTR2010-023347-14-BE
Date of registration:	04/01/2011
Prospective Registration:	Yes
Primary sponsor:	Gastroenterology CHC Liege
Public title:	Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LAR An open pilot study
Scientific title:	Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LAR An open pilot study
Date of first enrolment:	02/03/2011
Target sample size:
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023347-14
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Belgium

Contacts

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Key inclusion & exclusion 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:
- 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn Disease refractory diarrhoea
MedDRA version: 12.1 Level: LLT Classification code 10066533 Term: Diarrhea recurrent

Intervention(s)

Trade Name: Sandostatine
Product Name: sandostatine
Pharmaceutical Form: Injection*

Trade Name: Sandostatine
Product Name: sandostatine
Pharmaceutical Form: Injection*

Primary Outcome(s)

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

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.

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

Secondary Outcome(s)

Secondary ID(s)

2010-10

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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