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Completed

NCT Number: NCT00595140

Acute Application of Pegvisomant and Octreotide in Acromegaly

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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Klinik - Innenstadt of the University of Munich

Munich, 80336, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegvisomant

Drug

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

combination with somatostatin analogue octreotide

Drug

s.c., 100µg, one time

Other names: Octreotide: Sandostatin 100µg: MA number 29423.01.00

combination with dopamine agonist cabergoline

Drug

oral, 0.5mg, one time

Other names: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00

Primary outcomes

  1. The decrease of endogenous growth hormone

    Time frame: 6 or 9 hours

Secondary outcomes

  1. The course of glucose, insulin and pegvisomant during the profiles

    Time frame: 6 or 9 hours

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 16, 2008
Registry last updated
Apr 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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