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A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury (GHD)

Primary Purpose

Brain Injuries, Growth Hormone Deficiency Dwarfism

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

somatropin

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

Active systemic malignancy or active intracranial tumor
Growth hormone replacement therapy in the last 12 months
History of dementia unrelated to traumatic brain injury

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline

Number of patients with abnormal GH stimulation tests

Secondary Outcome Measures

Change from baseline in waist circumference

Age and gender specific optimal doses of GH replacement

Change in Quality of Life-Adult Growth Hormone Deficiency Assessment

Assessment of adverse events

Serum prolactin, thyroid stimulating hormone, free thyroxine serum, cortisol, adrenocorticotropic hormone, luteinizing hormone, follicle stimulating hormone, estradiol, and testosterone to assess degree of other anterior pituitary hormone deficiencies

Change from baseline in Glasgow Outcome Score

Change in Quality of Life-Mini-Mental scores

Full Information

NCT ID

NCT00638053

First Posted

March 11, 2008

Last Updated

March 27, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00638053

Brief Title

A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury

Acronym

GHD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Terminated

Why Stopped

See reason for termination in detailed description.

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries, Growth Hormone Deficiency Dwarfism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

somatropin

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline

Time Frame

Months 1 thru 11

Title

Number of patients with abnormal GH stimulation tests

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Change from baseline in waist circumference

Time Frame

Month 12

Title

Age and gender specific optimal doses of GH replacement

Time Frame

Months 1 thru 11

Title

Change in Quality of Life-Adult Growth Hormone Deficiency Assessment

Time Frame

Months 1 thru 12

Title

Assessment of adverse events

Time Frame

Months 1 thru 12

Title

Time Frame

Baseline

Title

Change from baseline in Glasgow Outcome Score

Time Frame

Month 12

Title

Change in Quality of Life-Mini-Mental scores

Time Frame

Months 1 thru 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: Active systemic malignancy or active intracranial tumor Growth hormone replacement therapy in the last 12 months History of dementia unrelated to traumatic brain injury

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Pfizer Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79925

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Pfizer Investigational Site

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=GENGHD-0018-078&StudyName=A%20Study%20to%20Evaluate%20the%20Efficacy%20of%20Somatropin%20in%20Adults%20with%20Growth%20Hormone%20Deficiency%20Caused%20by%20Trauma%20and/or%20Head%20Injury%20

Description

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Learn more about this trial

A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury

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