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

January 7, 2008
March 31, 2008
January 2008
March 2008   (final data collection date for primary outcome measure)
The decrease of endogenous growth hormone [ Time Frame: 6 or 9 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00595140 on ClinicalTrials.gov Archive Site
The course of glucose, insulin and pegvisomant during the profiles [ Time Frame: 6 or 9 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acute Application of Pegvisomant and Octreotide in Acromegaly
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
  • 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
  • Drug: combination with somatostatin analogue octreotide
    s.c., 100µg, one time
    Other Name: Octreotide: Sandostatin 100µg: MA number 29423.01.00
  • Drug: combination with dopamine agonist cabergoline
    oral, 0.5mg, one time
    Other Name: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00
  • No Intervention: 1
    patients with acromegaly on stable pegvisomant therapy
    Intervention: Drug: pegvisomant
  • Active Comparator: 2
    Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
    Intervention: Drug: combination with somatostatin analogue octreotide
  • Active Comparator: 3
    Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally
    Intervention: Drug: combination with dopamine agonist cabergoline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00595140
EudraCT-Nr. 2007-005585-12, EudraCT-Nr. 2007-005585-12
No
PD Dr. Jochen Schopohl, Medizinische Klinik - Innenstadt of the University of Munich
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Jochen Schopohl, MD Medizinische Klinik - Innenstadt
Ludwig-Maximilians - University of Munich
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP