Ultrasound Guided Octreotide LAR Injection in Acromegaly

Brief Title

Ultrasound Guided Octreotide LAR Injection in Acromegaly

Official Title

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

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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Plasma Octreotide Level After Each Treatment Phase

Secondary Outcome

 Serum IGF-1 Level

Condition

Acromegaly

Intervention

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

15

Start Date

July 2007

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John Carmichael, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00552071

Organization ID

11482

Secondary IDs

CSMS995BUS60

Responsible Party

Principal Investigator

Study Sponsor

Cedars-Sinai Medical Center

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

John Carmichael, MD, Principal Investigator, University of Southern California

Verification Date

August 2018