Back to resultsPharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®
Primary Purpose
Acromegaly
Status
Suspended
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Octreotide acetate LAR
Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- Patients who have allergies to medicine;
- Patients with a history of acute pancreatitis;
- Patient with altered levels of amylase
Sites / Locations
- LAL Clínica Pesquisa e Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Octreotide acetate LAR 30 MG
Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Arm Description
Test
Outcomes
Primary Outcome Measures
Quantification of serum levels of GH and IGF-I.
Secondary Outcome Measures
Occurrence and severity of side effects during use of the product in order to ensure the security of it.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01086982
Brief Title
Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Study Start Date
March 2010 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azidus Brasil
4. Oversight
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Octreotide acetate LAR 30 MG
Arm Type
Experimental
Arm Description
Test
Arm Title
Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Octreotide acetate LAR
Intervention Description
30 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Intervention Description
30 mg, single dose
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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;
Patients who have allergies to medicine;
Patients with a history of acute pancreatitis;
Patient with altered levels of amylase
Facility Information:
Facility Name
LAL Clínica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®
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