Clinical trial NCT00068029: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-09-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary outcomes:
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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Fitzroy
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Fizroy
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: SÃ£o Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montpellier Cedex
country: France
facility: Pfizer Investigational Site
city: Nice Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Col La Raza
country: Mexico
facility: Pfizer Investigational Site
state: Mexico Df
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
state: Antrim
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Oxford
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: