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Pegvisomant And Sandostatin LAR Combination Study

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pegvisomant/ Sandostatin LAR
Sandostatin LAR
Pegvisomant
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2003
Last Updated
April 3, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00068029
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pegvisomant/ Sandostatin LAR
Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Primary Outcome Measure Information:
Title
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Pfizer Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pfizer Investigational Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Fizroy
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-060
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Nice Cedex
ZIP/Postal Code
06202
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hannover
Country
Germany
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Messina
ZIP/Postal Code
98122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Col La Raza
State/Province
Mexico Df
ZIP/Postal Code
02990
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Nijmegen
ZIP/Postal Code
6500 GA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Pfizer Investigational Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=PEGA-0435-005&StudyName=Pegvisomant+And+Sandostatin+LAR+Combination+Study
Description
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Learn more about this trial

Pegvisomant And Sandostatin LAR Combination Study

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