Open Label Study of Octreotide Implant in Patients With Acromegaly

Endo USA Inc., a Keenova Therapeutics Company34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

octreotide acetateDRUG

subcutaneous implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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