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Pegvisomant And Sandostatin LAR Combination Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00068029
Recruitment Status : Completed
First Posted : September 5, 2003
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Pegvisomant/ Sandostatin LAR Drug: Sandostatin LAR Drug: Pegvisomant Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2003
Actual Study Completion Date : May 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects experiencing treatment-emergent adverse events across the duration fo the study

Secondary Outcome Measures :
  1. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068029


Locations
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United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22908
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Pfizer Investigational Site
Fitzroy, Victoria, Australia, 3165
Pfizer Investigational Site
Fizroy, Victoria, Australia, 3165
Brazil
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21941-590
Pfizer Investigational Site
São Paulo, SP, Brazil, 05403-060
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 1X5
France
Pfizer Investigational Site
Montpellier Cedex, France, 34295
Pfizer Investigational Site
Nice Cedex, France, 06202
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Hannover, Germany
Italy
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Messina, Italy, 98122
Pfizer Investigational Site
Milano, Italy, 20162
Pfizer Investigational Site
Torino, Italy
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 06720
Pfizer Investigational Site
Col La Raza, Mexico Df, Mexico, 02990
Netherlands
Pfizer Investigational Site
Nijmegen, Netherlands, 6500 GA
Norway
Pfizer Investigational Site
Oslo, Norway, 0027
Spain
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08906
Pfizer Investigational Site
Madrid, Spain, 28035
United Kingdom
Pfizer Investigational Site
Belfast, Antrim, United Kingdom, BT12 6BA
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00068029    
Other Study ID Numbers: PEGA-0435-005
A6291006
First Posted: September 5, 2003    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents