AcromegalyPhase 4NCT00552071

Ultrasound Guided Octreotide LAR Injection in Acromegaly

A Phase 4 study testing Octreotide LAR 30 MG Injection in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acromegaly
What is being tested?: Octreotide LAR 30 MG Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Mar 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

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

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
Being tested: Octreotide LAR 30 MG Injection
Keywords: Acromegaly, Octreotide LAR, Ultrasound guidance
Medical subject headings: Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Octreotide LAR 30 MG InjectionDrug
Also called Sandostatin LAR
Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.

Study groups in NCT00552071
Study group	Role	What they receive
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. Receives: 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 Receives: Drug: Octreotide LAR 30 MG Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (1)

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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Mar 2014

First posted1 Nov 2007 (estimated)
Study startJul 2007
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AcromegalyStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00552071
Sponsor's protocol ID: 11482
Other IDs: CSMS995BUS60
Status last verified: Aug 2018
First submitted: 31 Oct 2007
Last updated: 11 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly
ClinicalTrials.gov ID: NCT00552071
Acronym / sponsor ID: 11482
Conditions: Acromegaly
Keywords: Acromegaly, Octreotide LAR, Ultrasound guidance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Collaborators: Novartis Pharmaceuticals
Study start: Jul 2007
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 1 Nov 2007 (estimated)
Results: Posted 11 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ultrasound-guided IM injections of octreotide LAR	Experimental	Drug: Octreotide LAR 30 MG InjectionSubjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.
Regular IM injections of octreotide LAR	Active comparator	Drug: Octreotide LAR 30 MG InjectionSubjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Octreotide LAR 30 MG InjectionAlso: Sandostatin LARStable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.	Drug	Regular IM injections of octreotide LAR, Ultrasound-guided IM injections of octreotide LAR

Primary outcome

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.

1 secondary outcome

Serum IGF-1 Level
Time frame: 3 months

Results and safety

Results posted to the registry on 11 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasound-guided Injections Followed by Regular Injections	10	6
Regular Injections Followed by Ultrasound-guided Injections	11	9

Primary outcome: Plasma Octreotide Level After Each Treatment Phase

Time frame: 3 months. Mean (Standard Deviation). Unit: pg/mL

Measure	Ultrasound-guided Injections of Octreotide LAR n = 15	Regular Injections of Octreotide LAR n = 15
Value	885 (702)	1167 (1126)

Ultrasound-guided Injections of Octreotide LAR vs Regular Injections of Octreotide LAR: p = 0.40, t-test, 2 sided

Population analysed: Subjects were regrouped for analysis by treatment. Octreotide levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to octreotide levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrasound-guided Injections Followed by Regular Injections	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Regular Injections Followed by Ultrasound-guided Injections	0 of 11 (0%)	1 of 11 (9.1%)	1 of 11

Limitations and caveats (from the sponsor): Small number of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acromegaly

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Carmichael, MD principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Octreotide LAR 30 MG Injection in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Octreotide Level After Each Treatment Phase (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00552071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.