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Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191165
First received: September 12, 2005
Last updated: June 8, 2009
Last verified: June 2009
Results First Received: April 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Growth Hormone Deficiency
Intervention: 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
No text entered.

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
High Dose Somatropin Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
Label Dose Somatropin Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection

Participant Flow:   Overall Study
    High Dose Somatropin     Label Dose Somatropin  
STARTED     14     13  
COMPLETED     12     11  
NOT COMPLETED     2     2  
Adverse Event                 2                 0  
Protocol Violation                 0                 1  
Participant Moved Away                 0                 1  



  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
High Dose Somatropin Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
Label Dose Somatropin Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
Total Total of all reporting groups

Baseline Measures
    High Dose Somatropin     Label Dose Somatropin     Total  
Number of Participants  
[units: participants]
  14     13     27  
Age  
[units: years]
Mean ± Standard Deviation
  13.5  ± 1.2     13.0  ± 1.5     13.3  ± 1.3  
Gender  
[units: participants]
     
Female     1     3     4  
Male     13     10     23  
Region of Enrollment  
[units: participants]
     
Italy     14     13     27  
Race/Ethnicity  
[units: participants]
     
Caucasian     14     12     26  
Other     0     1     1  
Baseline Predicted Height [1]
[units: centimeters]
Mean ± Standard Deviation
  168  ± 6.8     169  ± 10.7     168  ± 8.7  
Baseline Predicted Height Standard Deviation Score (SDS) [2]
[units: standard deviation score]
Mean ± Standard Deviation
  -0.9  ± 0.8     -0.5  ± 1.0     -0.7  ± 0.9  
Body Mass Index [3]
[units: kilograms per square meter (kg/m2)]
Mean ± Standard Deviation
  18.9  ± 3.2     19.4  ± 3.7     19.2  ± 3.4  
Bone Age [4]
[units: years]
Mean ± Standard Deviation
  12.4  ± 0.7     12.1  ± 1.0     12.2  ± 0.8  
Height [5]
[units: centimeters]
Mean ± Standard Deviation
  145  ± 5.1     146  ± 7.8     145  ± 6.5  
Height Standard Deviation Score (SDS) [6]
[units: standard deviation score]
Mean ± Standard Deviation
  -1.7  ± 1.0     -1.1  ± 1.0     -1.4  ± 1.0  
Target Height [7]
[units: centimeters]
Mean ± Standard Deviation
  168  ± 5.0     168  ± 7.5     168  ± 6.2  
Target Height Standard Deviation Score (SDS) [8]
[units: standard deviation score]
Mean ± Standard Deviation
  -0.9  ± 0.7     -0.6  ± 0.5     -0.8  ± 0.6  
[1]

Bone age, chronological age, gender, and height at Visit 0 were used to calculate the Baseline Predicted Height (BLPH) using the method of Bayley and Pinneau.

Bone age for the BLPH was based on the Greulich-Pyle bone age assessment of the Visit 0 bone age x-ray.

[2] BLPH expressed as a height SDS value (height SDS was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height standard deviation) using the British standards at age 18 for boys and 16 for girls.
[3] Body mass index is an estimate of body fat based on body weight divided by height squared.
[4] Bone age was determined by the Greulich-Pyle method.
[5] Standing measurements were to be made using a standard wall-mounted stadiometer.
[6] Height SDS was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height standard deviation (SD).
[7] Target Height represents the approximate adult height that the patient could be expected to attain, based on the heights of her/his parents. This is a gender-adjusted, average height of the patient’s parents’ heights calculated in centimeters, modified from the method of Tanner et al.
[8] Target height expressed as height SDS value (see height SDS description for how height SDS value was derived) based on patient’s gender, compared to British reference population at age 18 years for males and 16 years for females.



  Outcome Measures
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1.  Primary:   Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint   [ Time Frame: 12-Months ]

2.  Secondary:   Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS)   [ Time Frame: Baseline, 12-Months, 24-Months ]

3.  Secondary:   Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint   [ Time Frame: 24 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191165     History of Changes
Other Study ID Numbers: 5202, B9R-IT-GDFU
Study First Received: September 12, 2005
Results First Received: April 7, 2009
Last Updated: June 8, 2009
Health Authority: Italy: Ministry of Health