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

Azidus

Status and phase

Suspended

Phase 1

Conditions

Acromegaly

Treatments

Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG

Drug: Octreotide acetate LAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT01086982

OCTBER0409

Version 3

Details and patient eligibility

About

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

Full 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

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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