Pegvisomant And Sandostatin LAR Combination Study

April 3, 2008 updated by: Pfizer

A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly

The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

75

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

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Victoria
      • Fitzroy, Victoria, Australia, 3165
        • Pfizer Investigational Site
      • Fizroy, Victoria, Australia, 3165
        • Pfizer Investigational Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-590
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brazil, 05403-060
        • Pfizer Investigational Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Pfizer Investigational Site
  • France
      • Montpellier Cedex, France, 34295
        • Pfizer Investigational Site
      • Nice Cedex, France, 06202
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Dresden, Germany, 01307
        • Pfizer Investigational Site
      • Hannover, Germany
        • Pfizer Investigational Site
  • Italy
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Messina, Italy, 98122
        • Pfizer Investigational Site
      • Milano, Italy, 20162
        • Pfizer Investigational Site
      • Torino, Italy
        • Pfizer Investigational Site
  • Mexico
    • DF
      • Mexico, DF, Mexico, 06720
        • Pfizer Investigational Site
    • Mexico Df
      • Col La Raza, Mexico Df, Mexico, 02990
        • Pfizer Investigational Site
  • Netherlands
      • Nijmegen, Netherlands, 6500 GA
        • Pfizer Investigational Site
  • Norway
      • Oslo, Norway, 0027
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28035
        • Pfizer Investigational Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08906
        • Pfizer Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Pfizer Investigational Site
      • London, United Kingdom, EC1A 7BE
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 7EH
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Pfizer Investigational Site
      • Oxford, United Kingdom, OX3 7LJ
        • Pfizer Investigational Site
    • Antrim
      • Belfast, Antrim, United Kingdom, BT12 6BA
        • Pfizer Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Pfizer Investigational 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of acromegaly
  • Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
  • Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment

Exclusion Criteria:

  • Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
  • Patients on current medical therapy other than Sandostatin LAR
  • AST/ALT >= 3xULN (upper limits of normal)
  • Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
  • Visual field defects (except post-surgical stable residual defects)
  • Unable to self administer drug
  • Radiotherapy within 12 months of entering the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study

Secondary Outcome Measures

Outcome Measure
Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

October 1, 2003

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 4, 2003

First Submitted That Met QC Criteria

September 4, 2003

First Posted (Estimate)

September 5, 2003

Study Record Updates

Last Update Posted (Estimate)

April 7, 2008

Last Update Submitted That Met QC Criteria

April 3, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGA-0435-005
  • A6291006

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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