Ultrasound Guided Octreotide LAR Injection in Acromegaly

• Sponsor: Cedars-Sinai Medical Center
• Collaborator: Novartis Pharmaceuticals
• Information provided by (Responsible Party): John Carmichael, University of Southern California

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acromegaly	Drug: Octreotide LAR 30 MG Injection	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	15 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly
Study Start Date :	July 2007
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ultrasound-guided IM injections of octreotide LAR; Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.	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.; Other Name: Sandostatin LAR
Active Comparator: Regular IM injections of octreotide LAR; Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months	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.; Other Name: Sandostatin LAR

Outcome Measures

Primary Outcome Measures :

1. Plasma Octreotide Level After Each Treatment Phase [ Time Frame: 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 :

1. Serum IGF-1 Level [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Locations

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Novartis Pharmaceuticals

Investigators

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Principal Investigator:	John Carmichael, MD	University of Southern California

More Information

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Responsible Party:	John Carmichael, Co Director, Pituitary Program At Keck Medical Center, University of Southern California
ClinicalTrials.gov Identifier:	NCT00552071 History of Changes
Other Study ID Numbers:	11482; CSMS995BUS60 ( Other Identifier: Other )
First Posted:	November 1, 2007
Results First Posted:	September 11, 2018
Last Update Posted:	September 11, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by John Carmichael, University of Southern California:

Acromegaly; Octreotide LAR; Ultrasound guidance

Additional relevant MeSH terms:

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Acromegaly; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Octreotide; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents