Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharmaceutical Bergamo Ltda., Compared To Product Sandostatin LAR ® (Octreotide Acetate LAR) 30 MG Manufactured By Novartis Biosciences S / A.

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

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
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Quantification of serum levels of GH and IGF-I.

Secondary Outcome

 Occurrence and severity of side effects during use of the product in order to ensure the security of it.

Condition

Acromegaly

Intervention

Octreotide acetate LAR

Study Arms / Comparison Groups

 Octreotide acetate LAR 30 MG

Description:  Test

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

16

Start Date

March 2010

Completion Date

May 2010

Primary Completion Date

May 2010

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Brazil

Location Countries

Brazil

NCT ID

NCT01086982

Organization ID

OCTBER0409

Secondary IDs

Version 3

Responsible Party

Principal Investigator

Study Sponsor

Azidus Brasil

Study Sponsor

, , 

Verification Date

November 2022