Open Label Study of Octreotide Implant in Patients With Acromegaly
Open Label Study of Octreotide Implant in Patients With Acromegaly
To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and
 non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of
 treatment.
An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30
 male and female patients with acromegaly. Eligible patients received 1 implant, either
 hydrated or non-hydrated, within 7 days of their Screening Visit. The octreotide implant was
 inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia.
 Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone
 (GH), and octreotide serum concentrations were collected at predetermined timepoints within
 the first 6 weeks after implantation.
Inclusion Criteria:

 -  Male and female patients with acromegaly

 -  Must be at least 18 years old

 -  Confirmed diagnosis of a growth hormone -secreting tumor

 -  Must be either a full or partial responder to octreotide demonstrated by historical
 laboratory values

 Exclusion Criteria:

 -  Women who are pregnant, lactating or of child-bearing potential who are not practicing
 a medically acceptable method of birth control

 -  Patients with liver disease

 -  Patients with symptomatic cholelithiasis

 -  Patients receiving radiotherapy for their pituitary tumor at any time before Screening