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Main
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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00565097 |
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Date of registration:
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28/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lanreotide as Treatment of Polycystic Livers
LOCKCYST |
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Scientific title:
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Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00565097 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Belgium
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Netherlands
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Contacts
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Name:
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Loes van Keimpema, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Medical Center Nijmegen |
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Name:
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Joost PH Drenth, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Medical Center Nijmegen |
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Name:
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Frederik Nevens, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Gasthuisberg, University of Leuven |
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Key inclusion & exclusion 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:
- Use of oral anticonceptives or estrogen suppletion
- Females who are pregnant or breast-feeding
- History or other evidence of chronic pulmonary disease associated with functional
limitation
- History of severe cardiac disease
- 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
- Renal failure requiring hemodialysis
Age minimum:
18 Years
Age maximum:
88 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatomegaly
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Polycystic Liver Disease
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Polycystic Kidney, Autosomal Dominant
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Liver Diseases
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Intervention(s)
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Drug: Lanreotide
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Drug: Placebo
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Primary Outcome(s)
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Reduction of total liver volume as determined by CT scan
[Time Frame: 6 months]
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Secondary Outcome(s)
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Symptom evaluation by (validated) questionnaires
[Time Frame: 6 months]
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Change of kidney volume and individual cyst volume on CT scan
[Time Frame: 6 months]
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Reduction of liver volume and individual cyst volume on CT scan.
[Time Frame: 6 months]
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Secondary ID(s)
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CMO 2007/010;ABR NL16194.091.0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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