Acute Application of Pegvisomant and Octreotide in Acromegaly

Ludwig Maximilian University of Munich

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: combination with somatostatin analogue octreotide; Drug: combination with dopamine agonist cabergoline; Drug: pegvisomant

Study type: Interventional

Funder types: Other

Identifiers

NCT00595140

EudraCT-Nr. 2007-005585-12

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

1

No Intervention group

Description:

patients with acromegaly on stable pegvisomant therapy

Treatment:

Drug: pegvisomant

2

Active Comparator group

Description:

Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg

Treatment:

Drug: combination with somatostatin analogue octreotide

3

Active Comparator group

Description:

Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally

Treatment:

Drug: combination with dopamine agonist cabergoline