Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients
Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01014793
Collaborator
(none)
19
1
43
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
19 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly
Study Start Date
:
May 1, 2005
Actual Primary Completion Date
:
May 1, 2007
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | 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) |
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Control of IGF-I levels [six months]
Secondary Outcome Measures
- control IGI-I levels [six months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Active disease, under octreotide treatment at least 9 months
Exclusion Criteria:
- Cabergoline allergy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74.
- Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D, Clemmons D, Chanson P, Laws E, Schlechte J, Vance ML, Ho K, Giustina A; Acromegaly Consensus Group. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009 May;94(5):1509-17. doi: 10.1210/jc.2008-2421. Epub 2009 Feb 10. Review.
- Rocheville M, Lange DC, Kumar U, Sasi R, Patel RC, Patel YC. Subtypes of the somatostatin receptor assemble as functional homo- and heterodimers. J Biol Chem. 2000 Mar 17;275(11):7862-9.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01014793
Other Study ID Numbers:
- Mattapr1
First Posted:
Nov 17, 2009
Last Update Posted:
Nov 17, 2009
Last Verified:
Nov 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: