Pegvisomant And Sandostatin LAR Combination Study

NCT ID: NCT00068029

Last Updated: 2008-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acromegaly

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pegvisomant/ Sandostatin LAR

Intervention Type DRUG

Sandostatin LAR

Intervention Type DRUG

Pegvisomant

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Pfizer Investigational Site

Charlottesville, Virginia, United States

Site Status

Pfizer Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

Pfizer Investigational Site

Fitzroy, Victoria, Australia

Site Status

Pfizer Investigational Site

Fizroy, Victoria, Australia

Site Status

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Pfizer Investigational Site

Toronto, Ontario, Canada

Site Status

Pfizer Investigational Site

Montpellier, , France

Site Status

Pfizer Investigational Site

Nice, , France

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Dresden, , Germany

Site Status

Pfizer Investigational Site

Hanover, , Germany

Site Status

Pfizer Investigational Site

Genova, , Italy

Site Status

Pfizer Investigational Site

Messina, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Torino, , Italy

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Pfizer Investigational Site

Col La Raza, Mexico DF, Mexico

Site Status

Pfizer Investigational Site

Nijmegen, , Netherlands

Site Status

Pfizer Investigational Site

Oslo, , Norway

Site Status

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Belfast, Antrim, United Kingdom

Site Status

Pfizer Investigational Site

Leeds, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Pfizer Investigational Site

Oxford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Brazil Canada France Germany Italy Mexico Netherlands Norway Spain United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6291006

Identifier Type: -

Identifier Source: secondary_id

PEGA-0435-005

Identifier Type: -

Identifier Source: org_study_id