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Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy (SGA-POWER)

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ClinicalTrials.gov Identifier: NCT00625872
Recruitment Status : Terminated (The study terminated on 19-Jan-2011 due to insufficient recruitment of patients. No safety reasons contributed to the termination of the study.)
First Posted : February 28, 2008
Results First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Growth Hormone Therapy
Infant, Small for Gestational Age
Intervention: Drug: Somatropin

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Somatropin Somatropin 0.035 milligram/kilogram/day (mg/kg/day) was administered subcutaneously (s.c) according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
Control Arm No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.

Participant Flow:   Overall Study
    Somatropin   Control Arm
STARTED   12   11 
Treated   12   10 
COMPLETED   8   5 
NOT COMPLETED   4   6 
Withdrawal by Subject                1                0 
Does not meet inclusion criteria                1                0 
Terminated by sponsor                2                5 
Randomized but not treated                0                1 



  Baseline Characteristics

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
Somatropin Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
Control Arm No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
Total Total of all reporting groups

Baseline Measures
   Somatropin   Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   11   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 6.6  (1.0)   7.6  (1.4)   7.1  (1.3) 
Gender 
[Units: Participants]
     
Female   3   8   11 
Male   9   3   12 


  Outcome Measures

1.  Primary:   Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6   [ Time Frame: Baseline and Month 6 ]

2.  Primary:   Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6   [ Time Frame: Baseline and Month 6 ]

3.  Primary:   Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6   [ Time Frame: Baseline and Month 6 ]

4.  Primary:   Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6   [ Time Frame: Baseline and Month 6 ]

5.  Primary:   Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6   [ Time Frame: Baseline and Month 6 ]

6.  Primary:   Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6   [ Time Frame: Baseline and Month 6 ]

7.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6   [ Time Frame: Baseline and Month 6 ]

8.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

9.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6   [ Time Frame: Baseline and Month 6 ]

10.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

11.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6   [ Time Frame: Baseline and Month 6 ]

12.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

13.  Secondary:   Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

14.  Secondary:   Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6 , Month 12 and Month 18 ]

15.  Secondary:   Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

16.  Secondary:   Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

17.  Secondary:   Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6   [ Time Frame: Baseline and Month 6 ]

18.  Secondary:   Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

19.  Secondary:   Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6   [ Time Frame: Baseline and Month 6 ]

20.  Secondary:   Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

21.  Secondary:   Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6   [ Time Frame: Baseline and Month 6 ]

22.  Secondary:   Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

23.  Secondary:   Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6   [ Time Frame: Baseline and Month 6 ]

24.  Secondary:   Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

25.  Secondary:   Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6 , Month 12 and Month 18 ]

26.  Secondary:   Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6 , Month 12 and Month 18 ]

27.  Secondary:   Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6 , Month 12 and Month 18 ]

28.  Secondary:   Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6   [ Time Frame: Baseline and Month 6 ]

29.  Secondary:   Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

30.  Secondary:   Mean Upper Arm Circumference   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

31.  Secondary:   Mean Thigh Circumference   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

32.  Secondary:   Mean Calf Circumference   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

33.  Secondary:   Mean Height at Month 6   [ Time Frame: Month 6 ]

34.  Secondary:   Mean Height at Months 12 and 18   [ Time Frame: Month 12 and Month 18 ]

35.  Secondary:   Mean Growth Velocity at Month 6   [ Time Frame: Month 6 ]

36.  Secondary:   Mean Growth Velocity at Months 12 and 18   [ Time Frame: Month 12 and Month 18 ]

37.  Secondary:   Mean Height-Standard Deviation Score (SDS) at Month 6   [ Time Frame: Month 6 ]

38.  Secondary:   Mean Height-Standard Deviation Score (SDS) at Months 12 and 18   [ Time Frame: Month 12 and Month 18 ]

39.  Secondary:   Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6   [ Time Frame: Month 6 ]

40.  Secondary:   Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18   [ Time Frame: Month 12 and Month 18 ]

41.  Secondary:   Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6   [ Time Frame: Baseline and Month 6 ]

42.  Secondary:   Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

43.  Secondary:   Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6   [ Time Frame: Baseline and Month 6 ]

44.  Secondary:   Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

45.  Secondary:   Sitting Height-Standard Deviation Score (SDS)   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

46.  Secondary:   Body Mass Index-Standard Deviation Score (BMI-SDS)   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

47.  Secondary:   Change From Baseline in Head Circumference at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

48.  Secondary:   Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

49.  Secondary:   Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6   [ Time Frame: Baseline and Month 6 ]

50.  Secondary:   Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18   [ Time Frame: Baseline, Month 12 and Month 18 ]

51.  Other Pre-specified:   Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

52.  Other Pre-specified:   Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]

53.  Other Pre-specified:   Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months   [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ]


  Serious Adverse Events


  Other Adverse Events


  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
The study was prematurely discontinued, therefore not all data was powered.


  More Information

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00625872     History of Changes
Other Study ID Numbers: A6281283
First Submitted: February 19, 2008
First Posted: February 28, 2008
Results First Submitted: January 27, 2012
Results First Posted: February 29, 2012
Last Update Posted: February 29, 2012