Acromegaly
Conditions
Keywords
Acromegaly,, growth hormone receptor antagonist,, somatostatin analogue,, combined medical treatment,, acute effect,, endogenous GH
Brief summary
The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.
Interventions
DRUGpegvisomant
growth hormone receptor antagonist pegvisomant in patients´ individual dose
DRUGcombination with somatostatin analogue octreotide
s.c., 100µg, one time
DRUGcombination with dopamine agonist cabergoline
oral, 0.5mg, one time
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with acromegaly currently on stable pegvisomant therapy * patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study * patients must not be co-treated with any other medication for acromegaly
Exclusion criteria
* radiotherapy within the last 2 years * any relevant acute disease * history of hypersensitivity against any of the used drugs * pregnancy or lactation * abnormal baseline findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease of endogenous growth hormone | 6 or 9 hours |
Secondary
| Measure | Time frame |
|---|---|
| The course of glucose, insulin and pegvisomant during the profiles | 6 or 9 hours |
Countries
Germany
Outcome results
None listed