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

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 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

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