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.

This study has suspended participant recruitment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01086982
First received: March 12, 2010
Last updated: October 26, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Acromegaly
Drug: Octreotide acetate LAR
Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Quantification of serum levels of GH and IGF-I. [ Time Frame: Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence and severity of side effects during use of the product in order to ensure the security of it. [ Time Frame: After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: March 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octreotide acetate LAR 30 MG
Test
Drug: Octreotide acetate LAR
30 mg, single dose
Active Comparator: Sandostatin LAR ® (octreotide acetate LAR) 30 MG Drug: Sandostatin LAR ® (octreotide acetate LAR) 30 MG
30 mg, single dose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086982

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01086982     History of Changes
Other Study ID Numbers: OCTBER0409, Version 3
Study First Received: March 12, 2010
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014