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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: |
NCT00765323 |
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Date of registration:
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30/09/2008 |
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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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Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
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Scientific title:
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Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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169 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00765323 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Czech Republic
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Germany
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Hungary
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Poland
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Russian Federation
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Serbia
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Slovakia
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Spain
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female patients with acromegaly
- Confirmed diagnosis of a growth hormone-secreting tumor
- Received a stable dose of monthly octreotide depot injections for a minimum of 3
consecutive months immediately prior to screening
- Must show a response to octreotide treatment with documented laboratory results at
the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal
age and sex-adjusted levels and GH = 2.5 ng/mL
Exclusion Criteria:
- Patients with pituitary surgery less than 3 months prior to screening
- Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9%
- Symptomatic cholelithiasis
- Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening,
or at any time during the trial
- Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any
time before Screening
Age minimum:
18 Years
Age maximum:
80 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: Sandostatin LAR Depot
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Drug: Octreotide Implant
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Primary Outcome(s)
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Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
[Time Frame: 12 months]
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Secondary ID(s)
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IP107-001
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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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