Acromegaly
Conditions
Keywords
microadenoma, macroadenoma
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).
Interventions
DRUGOctreotide acetate
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety and tolerability of multiple doses | — |
| The efect of octreotide acetate in the tumor efect | — |
| To evaluate the capability to reduce sign and symptoms of Acromegaly | — |
Countries
Mexico
Outcome results
None listed