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

Sponsored by:	Erasmus Medical Center
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00642720

Purpose

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:

To determine whether the addition of weekly pegvisomant administrations improves quality of life
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

Condition	Intervention	Phase
Quality of Life Acromegaly	Drug: Pegvisomant	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study
Official Title:	The Effects of Weekly Administration of 40 mg Pegvisomant or Placebo on Quality of Life and Insulin Sensitivity in Acromegalic Patients With Normal IGF-I Concentrations During Long-Term Treatment With Long-Acting Somatostatin Analogs

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

If the addition of pegvisomant will improve metabolic parameters such as Insulin sensitivity, lipids, Glucose, IGF-I ect. [ Time Frame: at 8 and 16 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	October 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Pegvisomant if the addition of 40 mg pegvisomant weekly will improve the quality of life of acromegaly patients compared to placebo weekly
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	Drug: Pegvisomant if the addition of 40 mg pegvisomant weekly will improve the quality of life of acromegaly patients compared to placebo weekly

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active acromegaly.
Serum total IGF-I levels must have been normalized during long-term treatment with long-acting somatostatin analogs
Age between 18 and 80

Exclusion Criteria:

Any contra-indication for the use of long-acting somatostatin analogs, as e.g. the use of anti-coagulants.
Subjects with pituitary tumors that compress the optic chiasm
Patients with insulin dependent diabetes
Patients with cancer
Patients with kidney- or liver function disturbances
Fertile female patients that refuse to take contraceptives during the study

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Erasmus Medical center ( Aart-Jan van der Lely )
Study ID Numbers:	P05.1649L, P05.1649L CCMO
Study First Received:	March 21, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00642720 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Quality of Life
Brain Diseases

Bone Diseases
Insulin
Somatostatin
Musculoskeletal Diseases
Endocrinopathy
Acromegaly

Additional relevant MeSH terms:

Bone Diseases, Endocrine
Hypothalamic Diseases
Hyperpituitarism
Pituitary Diseases
Musculoskeletal Diseases
Nervous System Diseases

Endocrine System Diseases
Central Nervous System Diseases
Brain Diseases
Bone Diseases
Acromegaly

ClinicalTrials.gov processed this record on May 07, 2009