Acute Application of Pegvisomant and Octreotide in Acromegaly

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: pegvisomant
* Drug: combination with somatostatin analogue octreotide
* Drug: combination with dopamine agonist cabergoline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>patients with acromegaly on stable pegvisomant therapy | Drug: pegvisomant<br>* growth hormone receptor antagonist pegvisomant in patients´ individual dose<br>* Other names: SOMAVERT 20 mg: EU/1/02/240/004;|
| Active Comparator: 2<br>Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg | Drug: combination with somatostatin analogue octreotide<br>* s.c., 100µg, one time<br>* Other names: Octreotide: Sandostatin 100µg: MA number 29423.01.00;|
| Active Comparator: 3<br>Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally | Drug: combination with dopamine agonist cabergoline<br>* oral, 0.5mg, one time<br>* Other names: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease of endogenous growth hormone |  | 6 or 9 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The course of glucose, insulin and pegvisomant during the profiles |  | 6 or 9 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly,, growth hormone receptor antagonist,, somatostatin analogue,, combined medical treatment,, acute effect,, endogenous GH