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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00163189
Other study ID # A6281271
Secondary ID 2004-002992-17
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2005
Est. completion date December 2014

Study information

Verified date June 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Glucocorticosteroid treatment for 12 months at least - Bone age < 15 years for a boy and < 13 years for a girl - Child measured height < - 2 SD, Child currently treated by GH Exclusion Criteria: - Known diabetes (type 1 or type 2) - A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Somatropin
Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day

Locations

Country Name City State
France Hôpital Nord Amiens
France Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie Annemasse Cedex
France Hôpital Saint Jacques Besancon Cedex
France Groupe hospitalier Est- Hôpital Femme, Mère, Enfant Bron
France Groupe hospitalier Est-Hôpital Femme, Mère, Enfant Bron
France CHU d'Estaing Clermont-Ferrand Cedex 1
France CHU de Grenoble, Hôpital Couple enfant. Grenoble Cedex 9
France CHU Timone Enfants Marseille Cedex 5
France Hôpital Arnaud De Villeneuve Montpellier
France CHU de Nantes, Hôpital Mère Enfant Nantes cedex 1
France Hôpital Lenval Nice
France Hôpital Armand Trousseau Paris
France Hôpital Robert Debré Paris
France Groupe Hospitalier Necker - Enfants Malades Paris cedex 15
France Centre de Perharidy Roscoff Cedex
France CHU Charles Nicolle Rouen Cedex
France Service de Pédiatrie- Centre Hospitalier Intercommunal Saint Germain-en-Laye Cedex
France Hôpital des Enfants Toulouse Cedex 9
France CHU Tours - Centre Pediatrique Gatien de Cocheville Tours Cedex 1

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs. Baseline up to 28 days after last study treatment
Other Number of Participants With Significant Changes in Physical Examinations Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement; Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)
Other Number of Participants With at Least 1 Medical or Surgical History Screening
Other Number of Participants Who Received Concomitant Medications Baseline up to Month 60
Other Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60
Other Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60 Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT). Screening, Month 12, 24, 36, 48, 60
Primary Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population 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; Yx refers to the value at particular timepoint x. 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. Baseline, Month 36
Primary Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population 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; Yx refers to the value at particular timepoint x. 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. Baseline, Month 36
Secondary Mean Height The standing height measurements were performed 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. Baseline, Month 12, 24, 36, 48, 60
Secondary Mean Height Standard Deviation Score (SDS) for Bone Age (BA) The standing height measurements were performed 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 BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. 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. Baseline, Month 12, 24, 36, 48, 60
Secondary Annual Growth Rate (AGR) AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled 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). Yx refers to the value at particular timepoint x. Baseline, Month 12, 24, 36, 48, 60
Secondary Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand. Month 12, 24, 36, 48, 60
Secondary Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. Baseline, Month 12, 24, 36, 48, 60
Secondary Body Mass Index (BMI) BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Baseline, Month 12, 24, 36, 48, 60
Secondary Change From Baseline in Height at Month 12, 24, 36, 48 and 60 The standing height measurements were performed 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. Baseline, Month 12, 24, 36, 48, 60
Secondary Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 The standing height measurements were performed 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; Yx refers to the value at particular timepoint x. 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. Baseline, Month 12, 24, 48, 60
Secondary Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60 The standing height measurements were performed 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 BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. 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. Baseline, Month 12, 24, 36, 48, 60
Secondary Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60 BA was estimated locally using an X-ray from the left wrist and hand. Baseline, Month 12, 24, 36, 48, 60
Secondary Ratio of Bone Age (BA) to Chronological Age (CA) 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. Baseline, Month 12, 24, 36, 48, 60
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