Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (IGHD)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00630487
First received: February 28, 2008
Last updated: February 26, 2013
Last verified: February 2013
Results First Received: August 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Growth Hormone Deficiency
Interventions: Drug: Placebo
Drug: Somatropin

  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
Study Initiation and Completion Dates: 26 May 2008 to 17 October 2008. The study was terminated prematurely.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Nine patients were enrolled, but no patients were randomized due to early termination of study.

Reporting Groups
  Description
Placebo No text entered.
Somatropin Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.

Participant Flow:   Overall Study
    Placebo     Somatropin  
STARTED     0     0  
COMPLETED     0     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
Somatropin Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
Total Total of all reporting groups

Baseline Measures
    Placebo     Somatropin     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age  
[units: participants]
     
<=18 years              
Between 18 and 65 years              
>=65 years              
Gender  
[units: participants]
     
Female              
Male              



  Outcome Measures
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1.  Primary:   Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)   [ Time Frame: Baseline, 52 weeks ]

2.  Secondary:   Change in Visceral Fat Mass in Subgroups   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

3.  Secondary:   Change From Baseline in Anthropometric Parameters (Height)   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

4.  Secondary:   Change From Baseline in Anthropometric Parameters (Weight)   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

5.  Secondary:   Change From Baseline in Anthropometric Parameters (Waist Circumference)   [ Time Frame: Baseline, 52 weeks, 78 weeks ]

6.  Secondary:   Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])   [ Time Frame: Baseline, Week 52, Week 78 ]

7.  Secondary:   Change From Baseline in Blood Pressure   [ Time Frame: Baseline, Week 52, Week 78 ]

8.  Secondary:   Change From Baseline in Heart Rate   [ Time Frame: Baseline, Week 52, Week 78 ]

9.  Secondary:   Change in Executive Function and Memory in Subgroups   [ Time Frame: Baseline, Week 52, Week 78 ]

10.  Secondary:   Change From Baseline in Safety Laboratory Assessments   [ Time Frame: Baseline, Week 52, Week 78 ]

11.  Secondary:   Change From Baseline in Homeostasis Model Assessment (HOMA)-Index   [ Time Frame: Baseline, Week 52, Week 78 ]

12.  Secondary:   Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)   [ Time Frame: Baseline, Week 52, Week 78 ]

13.  Secondary:   Change From Baseline in Short Form (36) Health Survey (SF36)   [ Time Frame: Baseline, Week 52, Week 78 ]

14.  Secondary:   Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)   [ Time Frame: Baseline, Week 52, Week 78 ]

15.  Secondary:   Change From Baseline in Cardiovascular Risk Factors   [ Time Frame: Baseline, Week 52, Week 78 ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


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: Pfizer
ClinicalTrials.gov Identifier: NCT00630487     History of Changes
Other Study ID Numbers: A6281282
Study First Received: February 28, 2008
Results First Received: August 3, 2010
Last Updated: February 26, 2013
Health Authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte