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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

Primary Purpose

Brain Injuries

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Genotropin (PN-180,307) Somatropin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    February 5, 2007
    Last Updated
    April 21, 2015
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00432263
    Brief Title
    Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.
    Official Title
    Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Genotropin (PN-180,307) Somatropin
    Primary Outcome Measure Information:
    Title
    The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6281274&StudyName=Treatment+Of+Adult+Growth+Hormone+Deficiency+After+Traumatic+Brain+Injury%2E
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

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