Clinical Trial Results:
Evolution of Growth Rate in Children Suffering From a Disease Associated With Growth Retardation and Treated by Genotonorm. A Pilot Study
Summary
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EudraCT number |
2004-002991-40 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
05 Oct 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
25 May 2016
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First version publication date |
22 Jul 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A6281269
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00163215 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Alias: 93-8122-001; CTN 93-8122-001 | ||
Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer Call Center, Pfizer Inc, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Mar 2012
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Oct 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To show an increase in annual growth rate (AGR) 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of growth hormone (GH) treatment.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Jan 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 46
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Worldwide total number of subjects |
46
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EEA total number of subjects |
46
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
25
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Adolescents (12-17 years) |
21
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
Pre-assignment
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Screening details |
Total number of subjects screened were 64, out of which 46 were enrolled in the study. The study was conducted in France which started on 17 January 2005 and completed on 05 October 2011. | ||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
Arms
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Arm title
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Genotonorm | ||||||||||||||
Arm 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. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Genotonorm
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Genotonorm was administered up to maximum of 50 mcg/kg/day, divided in 7 daily doses for up to 3 years.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
Subjects were administered with Genotonorm (recombinant somatropin) up to maximum of 50 mcg/kg/day subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Genotonorm
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Reporting 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. |
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End point 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 [1] | ||||||||||||
End point 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 subject was to reference population. Intent to Treat (ITT) set included all subjects 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 subjects evaluated at that time point.
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End point type |
Primary
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End point timeframe |
Baseline, Month 36
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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Notes [2] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population [3] | ||||||||||||
End point description |
Change in AGR, SDS for CA derived by subtracting AGR, SDS and 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 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 subject was to reference population. PP analysis set included all subjects in the ITT set without a major protocol violation. Here “n” signifies subjects evaluated at that time point.
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End point type |
Primary
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End point timeframe |
Baseline, Month 36
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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Notes [4] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | ||||||||||||||||
End point description |
Change in 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 subject 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). ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [5] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | ||||||||||||||||
End point description |
Change in 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 subject 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). PP analysis set included all subjects in the ITT set without a major protocol violation. Here “n” signifies subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [6] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Height | ||||||||||||||||
End point description |
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the subjects was measured two times and the mean of these measurements was recorded. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Height at Month 12, Month 24 and Month 36 | ||||||||||||||
End point description |
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the subjects was measured two times and the mean of these measurements was recorded. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [7] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Mean Height Standard Deviation Score (SDS) for Chronological Age (CA) | ||||||||||||||||
End point description |
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the subject 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 subject was to the reference population. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36 | ||||||||||||||
End point 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 subject was to the reference population. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [8] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | ||||||||||||||||
End point 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 subject was to the reference population. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [9] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36 | ||||||||||||||
End point 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 subjects was to the reference population. Here “n” signifies subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [10] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point 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 | ||||||||||||
End point 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 subject was to reference population. ITT set included all subjects who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24
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Notes [11] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point 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 | ||||||||||||
End point description |
Change in AGR, SDS for 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 subject was to reference population. PP analysis set included all subjects in the ITT set without a major protocol violation.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24
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Notes [12] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA) | ||||||||||||||
End point 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 subject 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 subject was to the reference population. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Month 12, Month 24, Month 36
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Notes [13] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Body Mass Index (BMI) | ||||||||||||||||
End point 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. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36 | ||||||||||||||
End point 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. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [14] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36 | ||||||||||||||||
End point description |
BA was estimated locally using an X-ray from the left wrist and hand. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [15] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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End point title |
Ratio of Bone Age (BA) to Chronological Age (CA) | ||||||||||||||||
End point 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. ITT set included all subjects 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 subjects evaluated at that time point.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12, Month 24, Month 36
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Notes [16] - N= (Number of subjects analyzed) signifies those subjects who were evaluable for this measure. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
AEs were collected from Baseline up to the end of treatment (month 36). SAEs were reported any time during the study through and including 28 days after the last dose of the study drug.
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Adverse event reporting additional 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 1 subject and as nonserious in another, or 1 subject may have experienced both serious, nonserious event during study. EU BR specific AE tables were generatedseparately as per EU format using latest coding.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Genotonorm
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Feb 2011 |
Following review of growth hormone (GH) data conducted by the European Medicines Agency (EMA) and the Committee for Medicinal Products for Human use (CHMP), the agencies had requested that the highest approved dose in Europe of 50 mcg/kg/day of recombinant human GH not be exceeded. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Certain GCP compliance issues noted at one site for this study. Impact on the study results from noted GCP compliance issues could not be fully assessed; however, it was considered that the results were compromised for the interpretation of efficacy |