Brief Title
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
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).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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 Outcome
Safety and tolerability of multiple doses
Condition
Acromegaly
Intervention
Octreotide acetate
Study Arms / Comparison Groups
Octreotide acetate
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
March 2003
Primary Completion Date
August 2005
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT00242541
Organization ID
CSMS995BMX02
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
April 2012