Acromegaly
Conditions
Brief summary
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acromegaly * Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment * Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment
Exclusion criteria
* Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations * Patients on current medical therapy other than Sandostatin LAR * AST/ALT \>= 3xULN (upper limits of normal) * Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI * Visual field defects (except post-surgical stable residual defects) * Unable to self administer drug * Radiotherapy within 12 months of entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects experiencing treatment-emergent adverse events across the duration fo the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific | — |
Countries
Australia, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom, United States
Outcome results
None listed