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Trial · Interventional

CompletedPhase 4Registry data

Acute Application of Pegvisomant and Octreotide in Acromegaly

NCTNCT00595140 (opens ClinicalTrials.gov in a new tab)Other idEudraCT-Nr. 2007-005585-12Other idEudraCT-Nr. 2007-005585-12
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
10 participants (actual)
Sponsor
Ludwig-Maximilians - University of Munich · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Jan 2008
Primary completion
Mar 2008
Completion
Mar 2008
First posted
16 Jan 2008 (estimated)
Last update posted
1 Apr 2008 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 4

    Acute Application of Pegvisomant and Octreotide in Acromegaly

    NCT00595140

    Jan 2008 to Mar 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • pegvisomantDrug
  • combination with somatostatin analogue octreotideDrug
  • combination with dopamine agonist cabergolineDrug

Arms3

  • No intervention

    1

    patients with acromegaly on stable pegvisomant therapy

  • Active comparator

    2

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

  • Active comparator

    3

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The decrease of endogenous growth hormone

    Time frame · 6 or 9 hours

Secondary outcomes(1)

  1. The course of glucose, insulin and pegvisomant during the profiles

    Time frame · 6 or 9 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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