Efficacy Of Somatropin In Patients With Isolated Growth Hormone Therapy
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Somatropin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
The study will investigate the effect on growth hormone replacement in patients with isolated
growth hormone deficiency on body composition, especially visceral fat mass.
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: The change of visceral fat mass assessed by magnetic resonance imaging scanning (MRI) after 52 weeks
Secondary outcome: Change in visceral fat mass in subgroups Change in cardiovascular risk factors (HDL, LDL, triglycerides) from baseline to week 52 and 78.Change from baseline in anthropometric parameters: height, weight, waist circumference after 52 and 78 weeks. Change in quality of life from baseline to week 52 and additionally to week 78 Incidence and number of adverse events Change in alertness and memory from baseline to week 52 and additionally to week 78 Change from baseline to week 52 and 78 in vital signs (BP, HR). Change in executive function and memory in subgroups Change from baseline to week 52 and 78 in safety laboratory assessments Change in HOMA-Index from baseline to week 52 and additionally to week 78
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Muenchen 80804, Germany; Recruiting
Pfizer Investigational Site, Bad Aibling 83043, Germany; Recruiting
Pfizer Investigational Site, Berlin 10117, Germany; Not yet recruiting
Pfizer Investigational Site, Mainz 55131, Germany; Not yet recruiting
Pfizer Investigational Site, Marburg 35043, Germany; Not yet recruiting
Pfizer Investigational Site, Magdeburg 39120, Germany; Not yet recruiting
Pfizer Investigational Site, Muenchen 80336, Germany; Not yet recruiting
Pfizer Investigational Site, Erlangen 91054, Germany; Not yet recruiting
Pfizer Investigational Site, Leipzig 04103, Germany; Not yet recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2008
Ending date: August 2010
Last updated: October 7, 2008
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