Acute Application of Pegvisomant and Octreotide in Acromegaly

NCT ID: NCT00595140

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-03-31

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.

Detailed Description

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Conditions

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Acromegaly

Keywords

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Acromegaly, growth hormone receptor antagonist, somatostatin analogue, combined medical treatment, acute effect, endogenous GH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

patients with acromegaly on stable pegvisomant therapy

Group Type NO_INTERVENTION

pegvisomant

Intervention Type DRUG

growth hormone receptor antagonist pegvisomant in patients´ individual dose

2

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

Group Type ACTIVE_COMPARATOR

combination with somatostatin analogue octreotide

Intervention Type DRUG

s.c., 100µg, one time

3

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

Group Type ACTIVE_COMPARATOR

combination with dopamine agonist cabergoline

Intervention Type DRUG

oral, 0.5mg, one time

Interventions

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pegvisomant

growth hormone receptor antagonist pegvisomant in patients´ individual dose

Intervention Type DRUG

combination with somatostatin analogue octreotide

s.c., 100µg, one time

Intervention Type DRUG

combination with dopamine agonist cabergoline

oral, 0.5mg, one time

Intervention Type DRUG

Other Intervention Names

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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 Octreotide: Sandostatin 100µg: MA number 29423.01.00 Cabergoline: Dostinex 0.5mg: MA number 32411.00.00

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Medizinische Klinik - Innenstadt of the University of Munich

Principal Investigators

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Jochen Schopohl, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik - Innenstadt

Locations

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Medizinische Klinik - Innenstadt of the University of Munich

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT-Nr. 2007-005585-12

Identifier Type: -

Identifier Source: secondary_id

EudraCT-Nr. 2007-005585-12

Identifier Type: -

Identifier Source: org_study_id