Acromegaly
Conditions
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
Interventions
DRUGOctreotide acetate LAR
30 mg, single dose
DRUGSandostatin LAR ® (octreotide acetate LAR) 30 MG
30 mg, single dose
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed