NCT00163189

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 25, 2015

Completed
Last Updated

February 21, 2024

Status Verified

June 1, 2015

Enrollment Period

9.9 years

First QC Date

September 9, 2005

Results QC Date

June 1, 2015

Last Update Submit

February 19, 2024

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (11)

  • Mean Height

    Baseline, Month 12, 24, 36, 48, 60

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

    Baseline, Month 12, 24, 36, 48, 60

  • Annual Growth Rate (AGR)

    Baseline, Month 12, 24, 36, 48, 60

  • Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)

    Month 12, 24, 36, 48, 60

  • Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)

    Baseline, Month 12, 24, 36, 48, 60

  • +6 more secondary outcomes

Other Outcomes (6)

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Baseline up to 28 days after last study treatment

  • Number of Participants With Significant Changes in Physical Examinations

    Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)

  • Number of Participants With at Least 1 Medical or Surgical History

    Screening

  • +3 more other outcomes

Study Arms (1)

Somatropin

EXPERIMENTAL
Drug: Somatropin

Interventions

SomatropinDRUG

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

Somatropin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hôpital Nord

Amiens, 80030, France

Location

Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie

Annemasse, 74107, France

Location

Hôpital Saint Jacques

Besançon, 25030, France

Location

Groupe hospitalier Est- Hôpital Femme, Mère, Enfant

Bron, 69677, France

Location

Groupe hospitalier Est-Hôpital Femme, Mère, Enfant

Bron, 69677, France

Location

CHU d'Estaing

Clermont-Ferrand, 63003, France

Location

CHU de Grenoble, Hôpital Couple enfant.

Grenoble, 38043, France

Location

CHU Timone Enfants

Marseille, 13385, France

Location

Hôpital Arnaud De Villeneuve

Montpellier, 34059, France

Location

CHU de Nantes, Hôpital Mère Enfant

Nantes, 44093, France

Location

Hôpital Lenval

Nice, 06200, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Hôpital Armand Trousseau

Paris, 75571, France

Location

Groupe Hospitalier Necker - Enfants Malades

Paris, 75743, France

Location

Centre de Perharidy

Roscoff, 29684, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

Service de Pédiatrie- Centre Hospitalier Intercommunal

Saint-Germain-en-Laye, 78105, France

Location

Hôpital des Enfants

Toulouse, 31059, France

Location

CHU Tours - Centre Pediatrique Gatien de Cocheville

Tours, 37044, France

Location

Related Publications (1)

  • Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.

    PMID: 30910221DERIVED

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 21, 2024

Results First Posted

June 25, 2015

Record last verified: 2015-06

Locations

FR(19)