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
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.
Plasma Octreotide Level After Each Treatment Phase
Serum IGF-1 Level
Octreotide LAR 30 MG Injection
Study Arms / Comparison Groups
Ultrasound-guided IM injections of octreotide LAR
Description: Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Diagnosis of active acromegaly based on evidence of a pituitary tumor - Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test - Previous treatment with a stable dose of octreotide LAR for at least 3 months - No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity Exclusion Criteria: - Uncontrolled diabetes mellitus - Pregnant or breast feeding - Current gallstones - History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic steatosis - Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix - History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy - History of investigational drugs administered or received within 30 days of study entry - Known hypersensitivity to octreotide LAR - Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor
18 Years - N/A
Accepts Healthy Volunteers
John Carmichael, MD, ,
Cedars-Sinai Medical Center
John Carmichael, MD, Principal Investigator, University of Southern California