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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- The decrease of endogenous growth hormone
- Time Frame: 6 or 9 hours
Safety Issue?: No
- Time Frame: 6 or 9 hours
Secondary Measures
- The course of glucose, insulin and pegvisomant during the profiles
- Time Frame: 6 or 9 hours
Safety Issue?: No
- Time Frame: 6 or 9 hours
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Ludwig-Maximilians - University of Munich Other
Overall Clinical Trial Officials and Contacts
Jochen Schopohl, MD Principal Investigator Medizinische Klinik - Innenstadt
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00595140
