Acromegaly
Conditions
Keywords
S-LAR, Octreotide, Implant
Brief summary
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.
Detailed description
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.
Interventions
DRUGoctreotide acetate
subcutaneous implant
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed