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NCT00595140 Clinical Trial

Acute Application of Pegvisomant and Octreotide in Acromegaly

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00595140
Other study ID # EudraCT-Nr. 2007-005585-12
Secondary ID EudraCT-Nr. 2007
Status Completed
Phase Phase 4
First received January 7, 2008
Last updated March 31, 2008
Start date January 2008
Est. completion date March 2008

Study information
Verified date January 2008
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Medizinische Klinik - Innenstadt of the University of Munich Munich

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary The decrease of endogenous growth hormone 6 or 9 hours No
Secondary The course of glucose, insulin and pegvisomant during the profiles 6 or 9 hours No
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Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3