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

NCT01086982 | Suspended Phase 1

• 2 other identifiers: OCTBER0409Version 3
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Octreotide acetate LAR 30 MG

EXPERIMENTAL

Test

Drug: Octreotide acetate LAR

Sandostatin LAR ® (octreotide acetate LAR) 30 MG

ACTIVE COMPARATOR

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

Interventions

Octreotide acetate LAR DRUG

30 mg, single dose

Octreotide acetate LAR 30 MG

Sandostatin LAR ® (octreotide acetate LAR) 30 MG DRUG

30 mg, single dose

Sandostatin LAR ® (octreotide acetate LAR) 30 MG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Alexandre Frederico

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BR (1)