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.
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;
Show all 9Show fewer
- 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.
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
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 factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
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
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.
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 factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly
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
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.
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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?
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.