Acute Application of Pegvisomant and Octreotide in Acromegaly

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT00595140

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: pegvisomant Drug: combination with somatostatin analogue octreotide Drug: combination with dopamine agonist cabergoline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 patients with acromegaly on stable pegvisomant therapy	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
Active Comparator: 2 Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg	Drug: combination with somatostatin analogue octreotide s.c., 100µg, one time Other Names: Octreotide: Sandostatin 100µg: MA number 29423.01.00
Active Comparator: 3 Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally	Drug: combination with dopamine agonist cabergoline oral, 0.5mg, one time Other Names: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00

Arm

Intervention/Treatment

No Intervention: 1

patients with acromegaly on stable pegvisomant therapy

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

Active Comparator: 2

Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg

Drug: combination with somatostatin analogue octreotide

s.c., 100µg, one time

Other Names:

Octreotide: Sandostatin 100µg: MA number 29423.01.00

Active Comparator: 3

Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally

Drug: combination with dopamine agonist cabergoline

oral, 0.5mg, one time

Other Names:

Cabergoline: Dostinex 0.5mg: MA number 32411.00.00

Outcome Measures

Primary Outcome Measures

The decrease of endogenous growth hormone [6 or 9 hours]

Secondary Outcome Measures

The course of glucose, insulin and pegvisomant during the profiles [6 or 9 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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