Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
54 participants
INTERVENTIONAL
2008-04-30
2009-08-31
Brief Summary
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Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
lanreotide
lanreotide
lanreotide
Interventions
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lanreotide
lanreotide
Eligibility Criteria
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Inclusion Criteria
* 18 yrs-of age
* Multiple cysts \> 20
* Cooperating patient
* Is willing and able to comply with the study drug regimen and all other study requirements.
* Willingness to give written informed consent
Exclusion Criteria
* Females who are pregnant or breast-feeding
* History or other evidence of chronic pulmonary disease associated with functional limitation
* History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
* History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Symptomatic gallstones (lanreotide decreases gall bladder volume)
* Renal failure requiring hemodialysis
18 Years
88 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Center
Principal Investigators
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Joost PH Drenth, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center
Frederik Nevens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Gasthuisberg, University of Leuven
Loes van Keimpema, MSc
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Medical Center
Locations
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University Hospital Gasthuisberg, University of Leuven
Leuven, , Belgium
Radboud University Nijmegen Medical Center
Nijmegen, , Netherlands
Countries
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References
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van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut. 2008 Sep;57(9):1338-9. doi: 10.1136/gut.2008.155721. No abstract available.
Other Identifiers
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NL16194.091.07
Identifier Type: -
Identifier Source: org_study_id