Acute Application of Pegvisomant and Octreotide in Acromegaly

Ludwig-Maximilians - University of Munich10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

pegvisomantDRUG

growth hormone receptor antagonist pegvisomant in patients´ individual dose

combination with somatostatin analogue octreotideDRUG

s.c., 100µg, one time

combination with dopamine agonist cabergolineDRUG

oral, 0.5mg, one time

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medizinische Klinik - Innenstadt of the University of Munich

Munich, Germany

Outcomes

Primary Outcomes

The decrease of endogenous growth hormone

Time frame: 6 or 9 hours

Secondary Outcomes

The course of glucose, insulin and pegvisomant during the profiles

Time frame: 6 or 9 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.