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Ultrasound Guided Octreotide LAR Injection in Acromegaly

Primary Purpose

Acromegaly

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Octreotide LAR 30 MG Injection

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, Octreotide LAR, Ultrasound guidance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-guided IM injections of octreotide LAR

Regular IM injections of octreotide LAR

Arm Description

Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00552071

First Posted

October 31, 2007

Last Updated

August 13, 2018

Sponsor

Cedars-Sinai Medical Center

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00552071

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

Keywords

Acromegaly, Octreotide LAR, Ultrasound guidance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound-guided IM injections of octreotide LAR

Arm Type

Experimental

Arm Description

Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.

Arm Title

Regular IM injections of octreotide LAR

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Octreotide LAR 30 MG Injection

Other Intervention Name(s)

Sandostatin LAR

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma Octreotide Level After Each Treatment Phase

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Serum IGF-1 Level

Description

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.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Carmichael, MD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Ultrasound Guided Octreotide LAR Injection in Acromegaly

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