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”

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.

Study Type: Interventional

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

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: pegvisomant
  • growth hormone receptor antagonist pegvisomant in patients´ individual dose
• Drug: combination with somatostatin analogue octreotide
  • s.c., 100µg, one time
• Drug: combination with dopamine agonist cabergoline
  • oral, 0.5mg, one time

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • patients with acromegaly on stable pegvisomant therapy
• Active Comparator: 2
  • Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
• Active Comparator: 3
  • Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally

Primary Measures

• The decrease of endogenous growth hormone
  • Time Frame: 6 or 9 hours
    Safety Issue?: No

Secondary Measures

• The course of glucose, insulin and pegvisomant during the profiles
  • Time Frame: 6 or 9 hours
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ludwig-Maximilians - University of Munich

Overall Clinical Trial Officials and Contacts

Jochen Schopohl, MD Principal Investigator Medizinische Klinik - Innenstadt  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00595140

Study ID Number: EudraCT-Nr. 2007-005585-12

ClinicalTrials.gov Identifier: NCT00595140

Health Authority: Germany: Federal Institute for Drugs and Medical Devices