Acute Application of Pegvisomant and Octreotide in Acromegaly - Full Text View

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00595140

Purpose

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.

Condition	Intervention	Phase
Acromegaly	Drug: pegvisomant Drug: combination with somatostatin analogue octreotide Drug: combination with dopamine agonist cabergoline	Phase IV

Drug Information available for: Dopamine Dopamine hydrochloride Octreotide Octreotide acetate Somatotropin Somatropin Cabergoline Cabergoline diphosphate Somatostatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

The decrease of endogenous growth hormone [ Time Frame: 6 or 9 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The course of glucose, insulin and pegvisomant during the profiles [ Time Frame: 6 or 9 hours ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	January 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention patients with acromegaly on stable pegvisomant therapy	Drug: pegvisomant growth hormone receptor antagonist pegvisomant in patients´ individual dose
2: Active Comparator Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg	Drug: combination with somatostatin analogue octreotide s.c., 100µg, one time
3: Active Comparator Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally	Drug: combination with dopamine agonist cabergoline oral, 0.5mg, one time

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595140

Locations

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

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

Principal Investigator:

Jochen Schopohl, MD

Medizinische Klinik - Innenstadt

More Information

Responsible Party:	Medizinische Klinik - Innenstadt of the University of Munich ( PD Dr. Jochen Schopohl )
Study ID Numbers:	EudraCT-Nr. 2007-005585-12, EudraCT-Nr. 2007-005585-12
Study First Received:	January 7, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00595140
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:

Acromegaly,
growth hormone receptor antagonist,
somatostatin analogue,

combined medical treatment,
acute effect,
endogenous GH

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Octreotide
Brain Diseases

Bone Diseases
Somatostatin
Dopamine
Musculoskeletal Diseases
Endocrinopathy
Cabergoline
Acromegaly

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists

Antiparkinson Agents
Dopamine Agonists
Hormones
Pharmacologic Actions
Hyperpituitarism
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009