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

April 25, 2012 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Octreotide acetate
Drug: Octreotide acetate
Other Names:
  • SMS995

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

October 9, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMS995BMX02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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