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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01014793
First received: November 16, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: cabergoline
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Control of IGF-I levels [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • control IGI-I levels [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

serum for IGI-I, GH and prolactin measures


Enrollment: 19
Study Start Date: May 2005
Study Completion Date: December 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Drug: cabergoline
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 Name: cabergoline-Dostinex

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Active disease, under octreotide treatment at least 9 months

Exclusion Criteria:

  • Cabergoline allergy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01014793

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04039030
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Julio Abucham, PhD Federal University of São Paulo
  More Information

Publications:

Responsible Party: Priscilla Olim de Andrade MAttar, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01014793     History of Changes
Other Study ID Numbers: Mattapr1
Study First Received: November 16, 2009
Last Updated: November 16, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Acromegaly resistant
combined-treatment
dopamine agonist

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Cabergoline
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014