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

Novartis

Status and phase

Terminated

Phase 4

Conditions

Acromegaly

Treatments

Drug: Octreotide acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242541

CSMS995BMX02

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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