Ultrasound Guided Octreotide LAR Injection in Acromegaly

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552071
• Other study ID #: 11482
• Secondary ID: CSMS995BUS60
• Status: Completed
• Phase: Phase 4
• Start date: July 2007
• Est. completion date: March 2014

Study information

• Verified date: August 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Octreotide Level After Each Treatment Phase	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.	3 months
Secondary	Serum IGF-1 Level	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.	3 months