Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Acute Application of Pegvisomant and Octreotide in Acromegaly

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

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
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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00595140

Medizinische Klinik - Innenstadt of the University of Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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 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:
growth hormone receptor antagonist,
somatostatin analogue,
combined medical treatment,
acute effect,
endogenous GH

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Dopamine Agonists
Anti-Dyskinesia Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014