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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

Page last updated: August 23, 2015

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