NCT00552071

Ultrasound Guided Octreotide LAR Injection in Acromegaly

Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Octreotide LAR 30 MG Injection	Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.

Timeline

• Start date: 2007-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2007-11-01
• Last updated: 2018-09-11
• Results posted: 2018-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study