Ultrasound Guided Octreotide LAR Injection in Acromegaly

NCT00552071 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 11482CSMS995BUS60
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Keywords

Acromegaly; Octreotide LAR; Ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum IGF-1 Level

  3 months

Study Arms (2)

Ultrasound-guided IM injections of octreotide LAR

EXPERIMENTAL

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

Regular IM injections of octreotide LAR

ACTIVE COMPARATOR

Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months

Drug: Octreotide LAR 30 MG Injection

Interventions

Octreotide LAR 30 MG Injection DRUG

Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.

Also known as: Sandostatin LAR

Regular IM injections of octreotide LAR; Ultrasound-guided IM injections of octreotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Injections

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

Small number of subjects analyzed

Results Point of Contact

• Title: Vivian Hwe
• Organization: Cedars-Sinai Medical Center

hwev@cshs.org

4224-315-4489

Study Officials

• John Carmichael, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co Director, Pituitary Program At Keck Medical Center

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 11, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)