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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00616408 |
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Date of registration:
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05/02/2008 |
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Primary sponsor: |
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Public title:
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Prediction of Tumor Shrinkage in Acromegaly
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Scientific title:
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Predictive Value of 3 Months Results on 12 Months Tumor Shrinkage After First-Line Octreotide-LAR Therapy in Patients With Acromegaly |
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Date of first enrolment:
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January 1997 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00616408 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Countries of recruitment
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Italy
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Contacts
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Name:
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Annamaria Colao, MD |
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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 Federico II of Naples |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- No previous treatment for acromegaly
Exclusion Criteria:
- primary surgery
- concomitant hyperprolactinemia requiring combined somatostatin analogues and
dopamine-agonist treatment
- primary treatment with lanreotide
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acromegaly
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Intervention(s)
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Drug: Octreotide-LAR
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Primary Outcome(s)
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GH and IGF-I age-normalized levels, percent GH and IGF-I suppression and percent tumor shrinkage after 3 months
[Time Frame: 12 months]
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Secondary Outcome(s)
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baseline age, gender, estimated disease duration, GH and IGF-I levels, tumor size
[Time Frame: 12 months]
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Secondary ID(s)
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NeuroendoUnit-8
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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