Acute Application of Pegvisomant and Octreotide in Acromegaly

Phase 4

Completed

• Conditions: Acromegaly
• Interventions: Drug: pegvisomant; Drug: combination with somatostatin analogue octreotide; Drug: combination with dopamine agonist cabergoline

• Registration Number: NCT00595140
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-01
• Study Start: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2008-03-31
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	pegvisomant	patients with acromegaly on stable pegvisomant therapy
2	combination with somatostatin analogue octreotide	Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
3	combination with dopamine agonist cabergoline	Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally

Primary Outcome Measures

Name	Time	Method
The decrease of endogenous growth hormone	6 or 9 hours

Secondary Outcome Measures

Name	Time	Method
The course of glucose, insulin and pegvisomant during the profiles	6 or 9 hours

Trial Locations

Locations (1)

Medizinische Klinik - Innenstadt of the University of Munich; 🇩🇪 Munich, Germany