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Acute Application of Pegvisomant and Octreotide in Acromegaly

Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acromegaly

Intervention: pegvisomant (Drug); combination with somatostatin analogue octreotide (Drug); combination with dopamine agonist cabergoline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ludwig-Maximilians - University of Munich

Official(s) and/or principal investigator(s):
Jochen Schopohl, MD, Principal Investigator, Affiliation: Medizinische Klinik - Innenstadt

Summary

The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100g 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.

Clinical Details

Official title: The Effect of Acute Application of Pegvisomant Alone and in Combination With Octreotide on Endogenous GH Levels During a 6 Hour Test in Patients With Acromegaly on Constant Pegvisomant Treatment

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The decrease of endogenous growth hormone

Secondary outcome: The course of glucose, insulin and pegvisomant during the profiles

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Medizinische Klinik - Innenstadt of the University of Munich, Munich 80336, Germany
Additional Information

Starting date: January 2008
Last updated: March 31, 2008

Page last updated: August 23, 2015

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