|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00555009 |
Purpose
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Injuries Growth Hormone Deficiency |
Drug: Genotropin Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury. |
| Enrollment: | 10 |
| Study Start Date: | March 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Genotropin treatment arm
Not Specified
|
Drug: Genotropin
Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
|
The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Pfizer Investigational Site | |
| Creteil Cedex, France, 94010 | |
| Pfizer Investigational Site | |
| Paris Cedex 13, France, 75651 | |
| Italy | |
| Pfizer Investigational Site | |
| Ferrara, Italy, 44100 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00168 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Rotterdam, Netherlands, 3015 GD | |
| Spain | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41013 | |
| Sweden | |
| Pfizer Investigational Site | |
| Göteborg, Sweden, 413 45 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 171 76 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Salford, Manchester, United Kingdom, M6 8HD | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00555009 History of Changes |
| Other Study ID Numbers: | A6281289 |
| Study First Received: | October 24, 2007 |
| Results First Received: | December 22, 2009 |
| Last Updated: | June 1, 2010 |
| Health Authority: | Italy: Agenzia Italiana del Farmaco (AIFA) |
|
traumatic brain Injury, cognitive function |
|
Dwarfism, Pituitary Brain Injuries Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases Hypothalamic Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |