Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

Acromegaly Clinical Trial

Official title:

Open Label Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00242541
• Other study ID #: CSMS995BMX02
• Status: Terminated
• Phase: Phase 4
• First received: October 9, 2005
• Last updated: April 25, 2012
• Start date: March 2003

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of octreotide acetate to decrease GH and IGF-I levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (> 10 mm).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female patients aged 18 - 80 years.

• Newly diagnosed or previously treated acromegalic patients.

• Lack of suppression of GH nadir to <1.0 microg/L, after oral administration of 75 g of glucose (OGTT).

• IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender).

Exclusion Criteria:

• Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.

• No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI).

• Symptomatic cholelithiasis.

• Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry.

• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphatase 2 x > upper limit of normal, or total bilirubin 1.5 x > upper limit of normal.

• Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Medically acceptable methods include oral birth control pills, intrauterine devices, or mechanical methods (e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). If oral contraception is used, the patient must have been practicing this method for at least two months prior to the screening visit and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended.

• History of immunocompromise, including a positive HIV test result (ELISA and Western blot).

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Octreotide acetate

Locations

Country	Name	City	State
Mexico	Novartis Investigative Site	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the use of octreotide acetate to reduce levels of GH and IGF-I in Acromegalic patients with micro (< 10 mm) and macroadenomas (> 10 mm)
Secondary	Safety and tolerability of multiple doses
Secondary	The efect of octreotide acetate in the tumor efect
Secondary	To evaluate the capability to reduce sign and symptoms of Acromegaly