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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Growth Retardation In Children With Special Pathological Conditions Or Disease

NCTNCT00163215 (opens ClinicalTrials.gov in a new tab)Other idA6281269
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
46 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Jan 2005
Primary completion
Oct 2011
Completion
Oct 2011
First posted
13 Sept 2005 (estimated)
Last update posted
19 Dec 2012 (estimated)
Conditions
Endocrine System Diseases

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 3

    Growth Retardation In Children With Special Pathological Conditions Or Disease

    NCT00163215

    Jan 2005 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To show an increase in annual growth rate 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 GH treatment.

Interventions

  • SomatropinDrug

Arms1

  • Experimental

    Somatropin

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population

    Time frame · Baseline, Month 36

    Registry 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.

  2. Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population

    Time frame · Baseline, Month 36

    Registry 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.

Secondary outcomes(15)

  1. Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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).

  2. Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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).

  3. Height

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  4. Change From Baseline in Height at Month 12, Month 24 and Month 36

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  5. Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  6. Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  7. Mean Height Standard Deviation Score (SDS) for Bone Age (BA)

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  8. Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  9. Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population

    Time frame · Baseline, Month 12, Month 24

    Registry 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.

  10. Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population

    Time frame · Baseline, Month 12, Month 24

    Registry 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.

  11. Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)

    Time frame · Month 12, Month 24, Month 36

    Registry 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.

  12. Body Mass Index (BMI)

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  13. Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

  14. Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry description

    BA was estimated locally using an X-ray from the left wrist and hand.

  15. Ratio of Bone Age (BA) to Chronological Age (CA)

    Time frame · Baseline, Month 12, Month 24, Month 36

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, Month 36

Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population

GroupValue (SDS)Spread
Genotonorm-1.291.79
Primary outcomeMean· Baseline, Month 36

Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population

GroupValue (SDS)Spread
Genotonorm-1.981.06
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline, Month 12, Month 24, Month 36

Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population

GroupValue (centimeter per year (cm/year))Spread
Genotonorm4.51.8
Secondary outcomeMean· Baseline, Month 12, Month 24, Month 36

Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population

GroupValue (cm/year)Spread
Genotonorm4.01.0
Secondary outcomeMean· Baseline, Month 12, Month 24, Month 36

Height

GroupValue (cm)Spread
Genotonorm123.917.3
Secondary outcomeMean· Baseline, Month 12, Month 24, Month 36

Change From Baseline in Height at Month 12, Month 24 and Month 36

GroupValue (cm)Spread
Genotonorm7.72.1
Secondary outcomeMean· Baseline, Month 12, Month 24, Month 36

Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)

GroupValue (SDS)Spread
Genotonorm-2.840.91
Secondary outcomeMean· Baseline, Month 12, Month 24, Month 36

Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36

GroupValue (SDS)Spread
Genotonorm0.410.42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
GenotonormGenotonorm (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.–4 / 4621 / 46

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 11 Years up to 13 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Bone age \< 13 years for a boy and \< 11 years for a girl * Naive child: Measured Height \< -2.5 SD for CA * Child currently treated by GH Exclusion Criteria: * Idiopathic short stature * Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

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