Pegvisomant And Sandostatin LAR Combination Study

Brief Title

Pegvisomant And Sandostatin LAR Combination Study

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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 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

Condition

Acromegaly

Intervention

Pegvisomant/ Sandostatin LAR

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

Start Date

October 2003

Completion Date

May 2006

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT00068029

Organization ID

PEGA-0435-005

Secondary IDs

A6291006

Study Sponsor

Pfizer

Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer

Verification Date

April 2008