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

Completed

• Conditions: Acromegaly
• Interventions: Drug: cabergoline

• Registration Number: NCT01014793
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-05
• Study Completion: 2008-12
• Status Verified: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Last Update Submitted: 2009-11-16
• Study First Posted: 2009-11-17
• Last Update Posted: 2009-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Active disease, under octreotide treatment at least 9 months

Exclusion Criteria

• Cabergoline allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Control of IGF-I levels	six months

Secondary Outcome Measures

Name	Time	Method
control IGI-I levels	six months

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil