A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury
NCT00638053
Last updated date
ABOUT THIS STUDY
The purpose of this study is to assess the prevalence of GHD in patients who sustain a head
injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH)
therapy in the treatment of GHD caused by trauma or head injury
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain Injuries, Growth Hormone Deficiency Dwarfism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Documented GHD
- Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Active systemic malignancy or active intracranial tumor
- Growth hormone replacement therapy in the last 12 months
- History of dementia unrelated to traumatic brain injury
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Brain Injuries, Growth Hormone Deficiency DwarfismA Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury
NCT00638053
- Pittsburgh, Pennsylvania
- El Paso, Texas
- Salt Lake City, Utah
- Federal Way, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury | |||
| Official Title ICMJE | Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury | |||
| Brief Summary | The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury | |||
| Detailed Description | The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Genetic: somatropin
Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Genetic: somatropin | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Estimated Enrollment ICMJE | 100 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | November 2003 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00638053 | |||
| Other Study ID Numbers ICMJE | GENGHD-0018-078 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||