NCT00913055

Open Label Study of Octreotide Implant in Patients With Acromegaly

An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	octreotide acetate	subcutaneous implant

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2009-06-03
• Last updated: 2011-07-14