Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

This study has been withdrawn prior to recruitment.

First Received: February 5, 2007 Last Updated: May 15, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00432263

Purpose

To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.

Condition	Intervention	Phase
Brain Injuries	Drug: Genotropin (PN-180,307) Somatropin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.

Secondary Outcome Measures:

Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular

Estimated Enrollment:	120
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have had a previous traumatic brain injury (more than 1 year and less than 5 years) prior to the screening visit.
Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

Exclusion Criteria:

Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432263

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

No publications provided

Study ID Numbers:	A6281274
Study First Received:	February 5, 2007
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00432263 History of Changes
Health Authority:	Unknown:

Study placed in the following topic categories:

Craniocerebral Trauma
Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Hypopituitary Dwarfism
Pituitary Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Endocrine System Diseases
Trauma, Nervous System

Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Growth Hormone Deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Endocrine System Diseases

Central Nervous System Diseases
Trauma, Nervous System
Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Brain Injuries

ClinicalTrials.gov processed this record on July 06, 2009