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

NCT ID: NCT00242541

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31

Brief 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).

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octreotide acetate

Group Type: EXPERIMENTAL

Octreotide acetate

Intervention Type: DRUG

Interventions

Octreotide acetate

Intervention Type: DRUG

Other Intervention Names

SMS995

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

CSMS995BMX02

Identifier Type: -

Identifier Source: org_study_id