Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

November 16, 2009 updated by: Federal University of São Paulo

Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly

In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Sao Paulo, SP, Brazil, 04039030
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant to octreotide were enrolled

Description

Inclusion Criteria:

  • Active disease, under octreotide treatment at least 9 months

Exclusion Criteria:

  • Cabergoline allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Responders to cabergoline
patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week)
cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal
Other Names:
  • cabergoline-Dostinex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Control of IGF-I levels
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
control IGI-I levels
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Julio Abucham, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

November 17, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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