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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014793
First Posted: November 17, 2009
Last Update Posted: November 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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 ]

Secondary Outcome Measures:
  • control IGI-I levels [ Time Frame: six months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 16, 2009
First Posted: November 17, 2009
Last Update Posted: November 17, 2009
Last Verified: November 2009

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
Octreotide
Cabergoline
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs