Clinical trial NCT00242541: Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas
Official title: Open Label Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acromegaly
Keywords: microadenoma
macroadenoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: 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 outcomes:
measure: Safety and tolerability of multiple doses
measure: The efect of octreotide acetate in the tumor efect
measure: To evaluate the capability to reduce sign and symptoms of Acromegaly
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: