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Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

NCT00652379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-01-26

No results posted yet for this study

Summary

The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy.

Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.

Conditions

Interventions

DRUG

Pegvisomant

Pegvisomant s.c 15-30 mg 2 times a week

DRUG

Somatostatin analog (lanreotide or octreotide)

Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • The Research Council for Health and Disease, Denmark

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens Otto L. Jørgensen, MD Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-11-30
Completion
2011-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652379 on ClinicalTrials.gov