Efficacy Of Somatropin In Patients With Isolated Growth Hormone Therapy - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00630487

Purpose

The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.

Condition	Intervention	Phase
Growth Hormone Deficiency	Drug: Placebo Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The change of visceral fat mass assessed by magnetic resonance imaging scanning (MRI) after 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in visceral fat mass in subgroups Change in cardiovascular risk factors (HDL, LDL, triglycerides) from baseline to week 52 and 78. [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change from baseline in anthropometric parameters: height, weight, waist circumference after 52 and 78 weeks. [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change in alertness and memory from baseline to week 52 and additionally to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 52 and 78 in vital signs (BP, HR). [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change in executive function and memory in subgroups [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 52 and 78 in safety laboratory assessments [ Time Frame: 78 weeks ] [ Designated as safety issue: Yes ]
Change in HOMA-Index from baseline to week 52 and additionally to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change in quality of life from baseline to week 52 and additionally to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Incidence and number of adverse events [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	May 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.
Verum: Active Comparator	Drug: Somatropin Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

Arms

Assigned Interventions

Placebo: Placebo Comparator

Drug: Placebo

Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.

Verum: Active Comparator

Drug: Somatropin

Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

Detailed Description:

The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females between 18 and 65 years of age
Isolated growth hormone deficiency

Exclusion Criteria:

Isolated growth hormone deficiency by childhood onset
Diabetes mellitus type 1 or 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630487

Locations

Germany
Pfizer Investigational Site
Muenchen, Germany, 80804
Pfizer Investigational Site
Bad Aibling, Germany, 83043

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6281282
Study First Received:	February 28, 2008
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00630487 History of Changes
Health Authority:	Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on February 08, 2010