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Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients

NCT00642720 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-03-25

No results posted yet for this study

Summary

Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and insulin sensitivity in acromegalic patients with normal serum IGF-I concentrations during long-term treatment with long-acting somatostatin analogs

Study Objectives:

1. To determine whether the addition of weekly pegvisomant administrations improves quality of life
2. To determine whether the addition of weekly pegvisomant administrations improves insulin sensitivity

Study Population: Acromegalic patients, who have normalized their serum IGF-I levels down to the upper 25 centiles of normality during long-term treatment with monthly injections of a long-acting somatostatin analogue Number of Subjects: 20

Procedures:

* Patients on treatment with Sandostatin LAR (SL) 20 - 30 mg per months i.m. or patients on treatment with Lanreotide autosolution (LA) 90 - 120 mg deep s.c. will be enrolled.
* For 4 months, all subjects will also receive weekly s.c. injections of either placebo or a fixed dose of 40 mg pegvisomant
* After a 4 weeks wash-out period, patients will switch from either placebo to pegvisomant or from pegvisomant to placebo
* Before, and after 2 and 4 months of each treatment period, serum efficacy parameters and quality of life (AcroQol ™/ PASQ™) will be assessed.
* Before and after 4 months of each treatment period, pituitary tumor size and insulin sensitivity (HOMA/SIGMA model) will be assessed. Duration of study: 9 months

Hypothesis:

•We postulate that co-administration of the growth hormone receptor antagonist pegvisomant will improve QoL and insulin sensitivity

Conditions

Interventions

DRUG

Pegvisomant

if the addition of 40 mg pegvisomant weekly will improve the quality of life of acromegaly patients compared to placebo weekly

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-07-31
Completion
2007-07-31

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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 NCT00642720 on ClinicalTrials.gov