Open Label Study of Octreotide Implant in Patients With Acromegaly
Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: octreotide acetate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Endo Pharmaceuticals
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.
Clinical Details
Official title: An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2007
Last updated: July 13, 2011
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