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

Status

Completed

Phase

Phase 4

Enrollment

20 participants (actual)

Sponsor

Erasmus Medical Center · Other

Design

Randomized · Triple masking

Countries

Not stated

Start

Oct 2006

Primary completion

Jul 2007

Completion

Jul 2007

First posted

25 Mar 2008 (estimated)

Last update posted

25 Mar 2008 (estimated)

Conditions

Quality of Life · Acromegaly

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

• Other

  pegvisomant-placebo

  patients in this arm received(as addition)for the first 8 weeks Pegvisomant and the later for 8 weeks Placebo. This was divided by a 4 weeks wash-out period.

• Other

  placebo-pegvisomant

  Patient received for the first 8 weeks Pegvisomant and after a wash out period of 4 weeks the received 8 of placebo treatment

1. To assess if the addition of pegvisomant weekly will improve Quality of life (QoL). QoL will be assessed by the PASQ and AcroQol questionnaires

   Time frame · at 8 and 16 weeks of treatment

No study cites this trial.