Acute Application of Pegvisomant and Octreotide in Acromegaly
Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: pegvisomant (Drug); combination with somatostatin analogue octreotide (Drug); combination with dopamine agonist cabergoline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ludwig-Maximilians - University of Munich Official(s) and/or principal investigator(s): Jochen Schopohl, MD, Principal Investigator, Affiliation: Medizinische Klinik - Innenstadt
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The decrease of endogenous growth hormone
Secondary outcome: The course of glucose, insulin and pegvisomant during the profiles
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Medizinische Klinik - Innenstadt of the University of Munich, Munich 80336, Germany
Additional Information
Starting date: January 2008
Last updated: March 31, 2008
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