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

NCT ID: NCT01086982

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-05-31

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

Conditions

Acromegaly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octreotide acetate LAR 30 MG

Test

Group Type: EXPERIMENTAL

Octreotide acetate LAR

Intervention Type: DRUG

30 mg, single dose

Sandostatin LAR ® (octreotide acetate LAR) 30 MG

Group Type: ACTIVE_COMPARATOR

Sandostatin LAR ® (octreotide acetate LAR) 30 MG

Intervention Type: DRUG

30 mg, single dose

Interventions

Octreotide acetate LAR

30 mg, single dose

Intervention Type: DRUG

Sandostatin LAR ® (octreotide acetate LAR) 30 MG

30 mg, single dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Azidus Brasil

Principal Investigator Dr. Alexandre Frederico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Version 3

Identifier Type: OTHER

Identifier Source: secondary_id

OCTBER0409

Identifier Type: -

Identifier Source: org_study_id