Trial · Interventional

CompletedPhase 4Results postedRegistry data

Ultrasound Guided Octreotide LAR Injection in Acromegaly

NCTNCT00552071Other id11482Other idCSMS995BUS60

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 15 participants (actual)
Sponsor: Cedars-Sinai Medical Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2007
Primary completion: Mar 2014
Completion: Mar 2014
First posted: 1 Nov 2007 (estimated)
Last update posted: 11 Sept 2018
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008201020122014

Ph 4
Ultrasound Guided Octreotide LAR Injection in Acromegaly
NCT00552071
Jul 2007 to Mar 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Octreotide LAR 30 MG InjectionDrug

Arms2

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.
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Plasma Octreotide Level After Each Treatment Phase
Time frame · 3 months
Registry 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.

Secondary outcomes(1)

Serum IGF-1 Level
Time frame · 3 months
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Plasma Octreotide Level After Each Treatment Phase

Group	Value (pg/mL)	Spread
Ultrasound-guided Injections of Octreotide LAR	885	702
Regular Injections of Octreotide LAR	1167	1126

Secondary and other outcome results(1)

Secondary outcomeMean· 3 months

Serum IGF-1 Level

Group	Value (percentage of upper limit of normal)	Spread
Ultrasound-guided Injections of Octreotide LAR	132	92
Regular Injections of Octreotide LAR	124	83

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Ultrasound-guided Injections Followed by Regular InjectionsSubjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months.	0 / 10	0 / 10	0 / 10
Regular Injections Followed by Ultrasound-guided InjectionsSubjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months.	1 / 11	0 / 11	1 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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