Open Label Study of Octreotide Implant in Patients With Acromegaly
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
34 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal