Acute Application of Pegvisomant and Octreotide in Acromegaly

March 31, 2008 updated by: Ludwig-Maximilians - University of Munich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80336
        • Medizinische Klinik - Innenstadt of the University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The decrease of endogenous growth hormone
Time Frame: 6 or 9 hours
6 or 9 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Jochen Schopohl, MD, Medizinische Klinik - Innenstadt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT-Nr. 2007-005585-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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