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Acute Application of Pegvisomant and Octreotide in Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00595140
First received: January 7, 2008
Last updated: March 31, 2008
Last verified: January 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: 1
patients with acromegaly on stable pegvisomant therapy
 Drug: pegvisomant
growth hormone receptor antagonist pegvisomant in patients´ individual dose
Other Names:
  • Pegvisomant:
  • SOMAVERT 10 mg: EU/1/02/240/001
  • SOMAVERT 15 mg: EU/1/02/240/002
  • SOMAVERT 20 mg: EU/1/02/240/003
  • SOMAVERT 20 mg: EU/1/02/240/004
Active Comparator: 2
Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
 Drug: combination with somatostatin analogue octreotide
s.c., 100µg, one time
Other Name: Octreotide: Sandostatin 100µg: MA number 29423.01.00
Active Comparator: 3
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
Other Name: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00

  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

No publications provided

Responsible Party: PD Dr. Jochen Schopohl, Medizinische Klinik - Innenstadt of the University of Munich
ClinicalTrials.gov Identifier: NCT00595140     History of Changes
Other Study ID Numbers: EudraCT-Nr. 2007-005585-12, EudraCT-Nr. 2007-005585-12
Study First Received: January 7, 2008
Last Updated: March 31, 2008
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

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Dopamine
Cabergoline
Octreotide
Somatostatin
 Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013