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Growth Retardation In Children With Special Pathological Conditions Or Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00163215
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Endocrine System Diseases
Intervention Drug: Somatropin
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Genotonorm
Hide Arm/Group Description Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Period Title: Overall Study
Started 46
Completed 31
Not Completed 15
Reason Not Completed
Lack of Efficacy             3
Withdrawal by Subject             5
Other             7
Arm/Group Title Genotonorm
Hide Arm/Group Description Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
10.3  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
12
  26.1%
Male
34
  73.9%
1.Primary Outcome
Title Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population
Hide Description Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: SDS
Baseline (n = 42) -1.29  (1.79)
Change at Month 36 (n = 26) 2.36  (1.98)
2.Primary Outcome
Title Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population
Hide Description Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: SDS
Baseline (n = 14) -1.98  (1.06)
Change at Month 36 (n = 12) 2.70  (2.02)
3.Secondary Outcome
Title Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population
Hide Description Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25).
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: centimeter per year (cm/year)
Baseline (n = 42) 4.5  (1.8)
Change at Month 12 (n = 36) 3.3  (2.9)
Change at Month 24 (n = 35) 2.5  (2.7)
Change at Month 36 (n = 26) 2.0  (2.0)
4.Secondary Outcome
Title Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population
Hide Description Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25).
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: cm/year
Baseline (n = 14) 4.0  (1.0)
Change at Month 12 (n = 14) 4.0  (1.0)
Change at Month 24 (n = 14) 2.5  (1.3)
Change at Month 36 (n = 12) 1.8  (1.1)
5.Secondary Outcome
Title Height
Hide Description Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here "n" signifies those participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (n = 44) 123.9  (17.3)
Month 12 (n = 39) 130.3  (17.5)
Month 24 (n = 39) 137.8  (16.9)
Month 36 (n = 27) 143.5  (15.8)
6.Secondary Outcome
Title Change From Baseline in Height at Month 12, Month 24 and Month 36
Hide Description Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: cm
Change at Month 12 (n = 39) 7.7  (2.1)
Change at Month 24 (n = 39) 14.9  (3.4)
Change at Month 36 (n = 27) 22.3  (3.7)
7.Secondary Outcome
Title Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)
Hide Description Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here "n" signifies those participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: SDS
Baseline (n = 44) -2.84  (0.91)
Month 12 (n = 39) -2.42  (0.98)
Month 24 (n = 39) -2.09  (1.08)
Month 36 (n = 27) -1.72  (0.96)
8.Secondary Outcome
Title Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36
Hide Description Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height - reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement - Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: SDS
Change at Month 12 (n = 39) 0.41  (0.42)
Change at Month 24 (n = 39) 0.81  (0.60)
Change at Month 36 (n = 27) 1.03  (0.62)
9.Secondary Outcome
Title Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
Hide Description Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: SDS
Baseline (n = 35) -0.71  (1.52)
Month 12 (n = 32) -0.55  (1.68)
Month 24 (n = 32) -0.49  (1.77)
Month 36 (n = 20) -0.30  (1.46)
10.Secondary Outcome
Title Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36
Hide Description Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height-reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: SDS
Change at Month 12 (n = 28) -0.05  (1.04)
Change at Month 24 (n = 27) 0.06  (1.36)
Change at Month 36 (n = 17) 0.05  (1.32)
11.Secondary Outcome
Title Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population
Hide Description Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.
Time Frame Baseline, Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: SDS
Change at Month 12 (n = 36) 3.23  (2.66)
Change at Month 24 (n = 35) 2.62  (2.05)
12.Secondary Outcome
Title Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population
Hide Description Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.
Time Frame Baseline, Month 12, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: SDS
Change at Month 12 (n = 14) 4.40  (2.12)
Change at Month 24 (n = 14) 2.97  (1.68)
13.Secondary Outcome
Title Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)
Hide Description AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.
Time Frame Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: SDS
Month 12 (n = 28) 1.06  (1.57)
Month 24 (n = 25) 0.46  (1.15)
Month 36 (n = 19) -0.01  (1.19)
14.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here "n" signifies those participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: kilogram per square meter (kg/m^2)
Baseline (n = 44) 16.57  (2.37)
Month 12 (n = 39) 16.96  (2.64)
Month 24 (n = 39) 17.59  (2.69)
Month 36 (n = 27) 17.67  (2.08)
15.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36
Hide Description BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Change at Month 12 (n = 39) 0.52  (1.01)
Change at Month 24 (n = 39) 1.30  (1.35)
Change at Month 36 (n = 27) 1.89  (1.61)
16.Secondary Outcome
Title Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36
Hide Description BA was estimated locally using an X-ray from the left wrist and hand.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: years
Baseline (n = 40) 8.70  (3.28)
Change at Month 12 (n = 28) 1.69  (0.90)
Change at Month 24 (n = 28) 2.60  (0.97)
Change at Month 36 (n = 21) 4.04  (1.09)
17.Secondary Outcome
Title Ratio of Bone Age (BA) to Chronological Age (CA)
Hide Description BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.
Time Frame Baseline, Month 12, Month 24, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants evaluated at that time point.
Arm/Group Title Genotonorm
Hide Arm/Group Description:
Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n = 40) 0.79  (0.15)
Month 12 (n = 30) 0.83  (0.15)
Month 24 (n = 32) 0.85  (0.12)
Month 36 (n = 23) 0.89  (0.14)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Genotonorm
Hide Arm/Group Description Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
All-Cause Mortality
Genotonorm
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Genotonorm
Affected / at Risk (%)
Total   4/46 (8.70%) 
Congenital, familial and genetic disorders   
Cryptorchism * 1  1/46 (2.17%) 
Infections and infestations   
Laryngitis * 1  1/46 (2.17%) 
Staphylococcal infection * 1  1/46 (2.17%) 
Staphylococcal sepsis * 1  1/46 (2.17%) 
Viral infection * 1  1/46 (2.17%) 
Injury, poisoning and procedural complications   
Head injury * 1  1/46 (2.17%) 
Investigations   
Weight decreased * 1  1/46 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Histiocytosis haematophagic * 1  1/46 (2.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Genotonorm
Affected / at Risk (%)
Total   21/46 (45.65%) 
Gastrointestinal disorders   
Diarrhoea * 1  2/46 (4.35%) 
Infections and infestations   
Bronchopulmonary aspergillosis allergic * 1  1/46 (2.17%) 
Influenza * 1  1/46 (2.17%) 
Laryngitis * 1  1/46 (2.17%) 
Nasopharyngitis * 1  1/46 (2.17%) 
Oral herpes * 1  2/46 (4.35%) 
Tracheitis * 1  1/46 (2.17%) 
Injury, poisoning and procedural complications   
Joint injury * 1  1/46 (2.17%) 
Ligament sprain * 1  1/46 (2.17%) 
Investigations   
Ammonia increased * 1  1/46 (2.17%) 
Metabolism and nutrition disorders   
Glucose tolerance impaired * 1  1/46 (2.17%) 
Insulin resistance * 1  1/46 (2.17%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/46 (2.17%) 
Back pain * 1  1/46 (2.17%) 
Bone pain * 1  1/46 (2.17%) 
Knee deformity * 1  1/46 (2.17%) 
Muscle spasms * 1  1/46 (2.17%) 
Rickets * 1  1/46 (2.17%) 
Scoliosis * 1  1/46 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Melanocytic naevus * 1  1/46 (2.17%) 
Nervous system disorders   
Headache * 1  5/46 (10.87%) 
Loss of consciousness * 1  1/46 (2.17%) 
Psychiatric disorders   
Abnormal behaviour * 1  1/46 (2.17%) 
Encopresis * 1  1/46 (2.17%) 
Renal and urinary disorders   
Enuresis * 1  1/46 (2.17%) 
Renal failure * 1  1/46 (2.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/46 (2.17%) 
Rhinitis allergic * 1  1/46 (2.17%) 
Sleep apnoea syndrome * 1  1/46 (2.17%) 
Skin and subcutaneous tissue disorders   
Nail disorder * 1  1/46 (2.17%) 
Seborrhoeic dermatitis * 1  1/46 (2.17%) 
Skin irritation * 1  1/46 (2.17%) 
Surgical and medical procedures   
Ear tube insertion * 1  1/46 (2.17%) 
Vascular disorders   
Haematoma * 1  1/46 (2.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00163215    
Other Study ID Numbers: A6281269
First Submitted: September 9, 2005
First Posted: September 13, 2005
Results First Submitted: October 2, 2012
Results First Posted: December 19, 2012
Last Update Posted: December 19, 2012