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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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14 October 2013 |
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Main ID: |
EUCTR2009-016082-29-BE |
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Date of registration:
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25/11/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Role of Lanreotide in the Management of Paraduodenal Pancreatitis - LPP
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Scientific title:
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Role of Lanreotide in the Management of Paraduodenal Pancreatitis - LPP |
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Date of first enrolment:
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10/03/2010 |
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Target sample size:
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60 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016082-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients with one or several of the following radiological criteria for paraduodenal pancreatitis will be selected to participate to the protocol: an occupying mass lesion in the pancreaticoduodenal groove (hypointense relative to the pancreatic tissue on T1-weighted images and iso or slightly hyperintense on T2-weighted images); duodenal-wall thickening; cysts in the groove or/and duodenal wall.8 Others inclusion criteria will be being 18 years or older and having the capacity to give an informed consent.
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 will include a current pregnancy and the evidence of neoplasia (digestive or other).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Paraduodenal pancreatitis
MedDRA version: 12.1
Level: LLT
Classification code 10009093
Term: Chronic pancreatitis
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Intervention(s)
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Trade Name: Somatuline Autogel 90 mg
Pharmaceutical Form: Solution for injection
CAS Number: 127984741
Other descriptive name: LANREOTIDE ACETATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: The aim of this study is to evaluate the efficacy of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis by radiological and clinical evaluation after 6 months
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Primary end point(s): Primary endpoint will be the radiological response (evaluated by magnetic resonance imaging) after 6 months of treatment and will be defined as any reduction of the duodenal-wall thickening, a reduction of >50% in the cyst size or the cyst number, and/or a reduction of >50% in the diameter of the biliary and/or the pancreatic ducts.
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Secondary Objective: The aim of this study is to evaluate the efficacy of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis by radiological and clinical evaluation after 3 months
The aim of this study is to evaluate the safety of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis
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Secondary ID(s)
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era-gastro-pancreas-001
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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