Ultrasound Guided Octreotide LAR Injection in Acromegaly

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Regular IM injections of octreotide LAR	Octreotide LAR 30 MG Injection	Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months
Ultrasound-guided IM injections of octreotide LAR	Octreotide LAR 30 MG Injection	Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.

Primary Outcome Measures

Name	Time	Method
Plasma Octreotide Level After Each Treatment Phase	3 months	Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.

Secondary Outcome Measures

Name	Time	Method
Serum IGF-1 Level	3 months	Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.