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

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Brief Title

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

Official Title

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

Brief Summary

      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 Type

Observational


Primary Outcome

Control of IGF-I levels

Secondary Outcome

 control IGI-I levels

Condition

Acromegaly

Intervention

cabergoline

Study Arms / Comparison Groups

 Responders to cabergoline
Description:  patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week)

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

19

Start Date

May 2005

Completion Date

December 2008

Primary Completion Date

May 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Active disease, under octreotide treatment at least 9 months

        Exclusion Criteria:

          -  Cabergoline allergy
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Julio Abucham, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01014793

Organization ID

Mattapr1



Study Sponsor

Federal University of São Paulo


Study Sponsor

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


Verification Date

November 2009