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Growth Hormone Treatment in Children Born Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184717
First received: September 13, 2005
Last updated: March 22, 2012
Last verified: March 2012
Results First Received: December 22, 2010  
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: Foetal Growth Problem
Small for Gestational Age
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
44 sites in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects completed the main period and were offered to continue in the extension period.

Reporting Groups
  Description
0.033 mg / NN-220 In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
0.067 mg / NN-220 In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
No Treatment No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
No Treatment --> 0.033 mg In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
No Treatment --> 0.067 mg In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Participant Flow for 2 periods

Period 1:   Main Period (GHLIQUID-1516)
    0.033 mg / NN-220     0.067 mg / NN-220     No Treatment     No Treatment --> 0.033 mg     No Treatment --> 0.067 mg  
STARTED     39     38     21     0     0  
Exposed to Trial Drug     38     38     21     0     0  
COMPLETED     36     36     20     0     0  
NOT COMPLETED     3     2     1     0     0  

Period 2:   Extension Period (GHLIQUID-1517)
    0.033 mg / NN-220     0.067 mg / NN-220     No Treatment     No Treatment --> 0.033 mg     No Treatment --> 0.067 mg  
STARTED     33 [1]   33 [1]   0 [2]   10 [3]   10 [3]
COMPLETED     23     27     0     7     5  
NOT COMPLETED     10     6     0     3     5  
[1] Three subjects did not continue in extension period
[2] Re-randomised to receive 0.033 or 0.067 mg
[3] Re-randomised from No treatment group



  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
0.033 mg / NN-220 In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
0.067 mg / NN-220 In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
No Treatment No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
Total Total of all reporting groups

Baseline Measures
    0.033 mg / NN-220     0.067 mg / NN-220     No Treatment     Total  
Number of Participants  
[units: participants]
  35     34     15     84  
Age  
[units: years]
Mean ± Standard Deviation
  5.46  ± 1.37     5.15  ± 1.2     5.09  ± 1.37     5.27  ± 1.3  
Gender  
[units: participants]
       
Female     11     14     8     33  
Male     24     20     7     51  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     0     0     0     0  
Not Hispanic or Latino     35     34     15     84  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     35     34     15     84  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     0     0     0     0  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
Japan     35     34     15     84  
Height  
[units: cm]
Mean ± Standard Deviation
  96.19  ± 8.48     94.57  ± 7.28     94.42  ± 8.48     95.22  ± 7.96  
Body weight  
[units: kg]
Mean ± Standard Deviation
  13.31  ± 2.55     12.62  ± 1.81     12.47  ± 2.93     12.88  ± 2.36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years   [ Time Frame: Week 0, week 260 ]

2.  Primary:   Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years   [ Time Frame: Week 0, week 208 ]

3.  Secondary:   Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years   [ Time Frame: Weeks 0-260 ]

4.  Secondary:   Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years   [ Time Frame: Weeks 0-208 ]

5.  Secondary:   Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years   [ Time Frame: Week 0, week 260 ]

6.  Secondary:   Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years   [ Time Frame: Week 0, week 208 ]

7.  Secondary:   Adverse Events - Subjects Received NN220 Treatment for 5 Years   [ Time Frame: Weeks 0-260 ]

8.  Secondary:   Adverse Events - Subjects Received NN220 Treatment for 4 Years   [ Time Frame: Weeks 0-208 ]


  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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided by Novo Nordisk A/S

Publications automatically indexed to this study:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184717     History of Changes
Obsolete Identifiers: NCT00184704
Other Study ID Numbers: GHLIQUID-1516, GHLIQUID-1517, JapicCTI-050137, JapicCTI-050132
Study First Received: September 13, 2005
Results First Received: December 22, 2010
Last Updated: March 22, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare