Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00555009

First received: October 24, 2007

Last updated: June 1, 2010

Last verified: March 2009

History of Changes

Results First Received: December 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Brain Injuries Growth Hormone Deficiency
Interventions:	Drug: Genotropin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Genotropin	Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
Placebo	Matching placebo injected SC.

Participant Flow: Overall Study

	Genotropin	Placebo
STARTED	4	6
COMPLETED	2	0
NOT COMPLETED	2	6
Withdrawal by Subject	0	1
Terminated by Sponsor	2	5

Baseline Characteristics

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Reporting Groups

	Description
Genotropin	Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
Placebo	Matching placebo injected SC.
Total	Total of all reporting groups

Baseline Measures

	Genotropin	Placebo	Total
Number of Participants [units: participants]	4	6	10
Age, Customized [units: participants]
<18 years	0	0	0
18 - 44 years	4	4	8
45-64 years	0	2	2
>=65 years	0	0	0
Gender [units: participants]
Female	0	0	0
Male	4	6	10

Outcome Measures

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1. Primary:

Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 [ Time Frame: Baseline, Week 36 ]

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2. Secondary:

Change From Baseline in CogState™ at Week 12 and 24. [ Time Frame: Baseline, Week 12 and 24 ]

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3. Secondary:

Change From Baseline in Lean Body Mass and Fat Mass at Week 36 [ Time Frame: Baseline, Week 36 ]

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4. Secondary:

Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 [ Time Frame: Baseline, Week 36 ]

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5. Secondary:

Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 [ Time Frame: Baseline, Week 36 ]

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6. Secondary:

Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 [ Time Frame: Baseline, Week 36 ]

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7. Secondary:

Change From Baseline in Cardiovascular Risk [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]

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8. Secondary:

Change From Baseline in Weight [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]

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9. Secondary:

Change From Baseline in Waist Circumference [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

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)

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