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

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01086982
• Other study ID #: OCTBER0409
• Secondary ID: Version 3
• Status: Suspended
• Phase: Phase 1
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: November 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 16
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Octreotide acetate LAR
30 mg, single dose
• Sandostatin LAR ® (octreotide acetate LAR) 30 MG
30 mg, single dose

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of serum levels of GH and IGF-I.		Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.
Secondary	Occurrence and severity of side effects during use of the product in order to ensure the security of it.		After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.