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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 7, 2008

Last Updated Date

March 31, 2008

Start Date ^ICMJE

January 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The decrease of endogenous growth hormone [ Time Frame: 6 or 9 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00595140 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The course of glucose, insulin and pegvisomant during the profiles [ Time Frame: 6 or 9 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acute Application of Pegvisomant and Octreotide in Acromegaly

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00595140

Other Study ID Numbers ^ICMJE

EudraCT-Nr. 2007-005585-12, EudraCT-Nr. 2007-005585-12

Has Data Monitoring Committee

Responsible Party

PD Dr. Jochen Schopohl, Medizinische Klinik - Innenstadt of the University of Munich

Study Sponsor ^ICMJE

Ludwig-Maximilians - University of Munich

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jochen Schopohl, MD

Medizinische Klinik - Innenstadt

Information Provided By

Ludwig-Maximilians - University of Munich

Verification Date

January 2008

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

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