AcromegalyPhase 1NCT01086982

Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®

A Phase 1 study testing Octreotide acetate LAR and Sandostatin LAR ® (octreotide acetate LAR) 30 MG in people with Acromegaly, run by Azidus Brasil at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ® (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity analysis of growth hormone (GH) and growth… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acromegaly
What is being tested?: Octreotide acetate LAR and Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteBrazil
Study dates: Mar 2010to May 2010
Phase: Phase 1
Are there results?: None posted in the registry

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

Accept the Terms of Consent;
be aged over 18, regardless of sex;
Patients with acromegaly who presented GH levels ≥ 2.5 ng / mL or no suppression of GH levels to less than 1 ng / mL after tolerance test glucose and IGF-I levels for age and sex;
Patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased GH and IGF-I;
Patients waiting hypophysectomy with increased levels of GH and IGF-I

Who cannot join

Have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study;
Have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study;
Have been treated with somastostatina analog or dopamine agonist in the last 2 months;
Present history of myocardial infarction, angina and / or heart failure;
Patients who present calculation of the gallbladder and have not undergone cholecystectomy;
Pregnant women and nursing;

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Patients who have allergies to medicine;
Patients with a history of acute pancreatitis;
Patient with altered levels of amylase

Trial locations and contacts

1 site in 1 country.

Brazil1 site

LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo

Other trials in Brazil

About this study

Official title: Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharm. Bergamo, Compared To Product Sandostatin LAR®30 MG Manufactured By Novartis Biosciences S/A

Read the detailed description

Secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose

Conditions: Acromegaly
Being tested: Octreotide acetate LAR, Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Medical subject headings: Acromegaly

What participants receive

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

Octreotide acetate LARDrug
30 mg, single dose
Sandostatin LAR ® (octreotide acetate LAR) 30 MGDrug
30 mg, single dose

Study groups in NCT01086982
Study group	Role	What they receive
Octreotide acetate LAR 30 MG	Experimental	Test Receives: Drug: Octreotide acetate LAR
Sandostatin LAR ® (octreotide acetate LAR) 30 MG	Active comparator	Not described Receives: Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG

What is being measured

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

Quantification of serum levels of GH and IGF-I.
Measured: Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.

Secondary outcomes (1)

Occurrence and severity of side effects during use of the product in order to ensure the security of it.
Measured: After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.

Timeline

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

Mar 2010May 2010

First posted15 Mar 2010 (estimated)
Study startMar 2010
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AcromegalyStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01086982
Sponsor's protocol ID: OCTBER0409
Other IDs: Version 3
Status last verified: Nov 2022
First submitted: 12 Mar 2010
Last updated: 3 Nov 2022
Results posted: 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 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharm. Bergamo, Compared To Product Sandostatin LAR®30 MG Manufactured By Novartis Biosciences S/A
ClinicalTrials.gov ID: NCT01086982
Acronym / sponsor ID: OCTBER0409
Conditions: Acromegaly
Phase: Phase 1
Study type: Interventional
Recruitment status: Suspended
Enrolment: 16 participants (estimated)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Study start: Mar 2010 (actual)
Primary completion: May 2010 (actual)
Study completion: May 2010
First posted: 15 Mar 2010 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Octreotide acetate LAR 30 MG	Experimental	Drug: Octreotide acetate LARTest
Sandostatin LAR ® (octreotide acetate LAR) 30 MG	Active comparator	Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG

Who may qualify

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

Key inclusion criteria (5 listed)

Accept the Terms of Consent;
be aged over 18, regardless of sex;
Patients with acromegaly who presented GH levels ≥ 2.5 ng / mL or no suppression of GH levels to less than 1 ng / mL after tolerance test glucose and IGF-I levels for age and sex;
Patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased GH and IGF-I;
Patients waiting hypophysectomy with increased levels of GH and IGF-I

Key exclusion criteria (9 listed)

Have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study;
Have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study;
Have been treated with somastostatina analog or dopamine agonist in the last 2 months;
Present history of myocardial infarction, angina and / or heart failure;
Patients who present calculation of the gallbladder and have not undergone cholecystectomy;

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 acetate LAR30 mg, single dose	Drug	Octreotide acetate LAR 30 MG
Sandostatin LAR ® (octreotide acetate LAR) 30 MG30 mg, single dose	Drug	Sandostatin LAR ® (octreotide acetate LAR) 30 MG

Primary outcome

Quantification of serum levels of GH and IGF-I.
Time frame: Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.

1 secondary outcome

Occurrence and severity of side effects during use of the product in order to ensure the security of it.
Time frame: After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Octreotide acetate LAR and Sandostatin LAR ® (octreotide acetate LAR) 30 MG in people with Acromegaly, run by Azidus Brasil at 1 site in Brazil.

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 5 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: paused, as of the sponsor's last update on 3 Nov 2022. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Results are not available in the source record.

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?

Quantification of serum levels of GH and IGF-I. (time frame: Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.). 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 NCT01086982.

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 3 Nov 2022.