NCT00174278

Brief Summary

To assess the effect of long-term treatment by Genotonorm on linear growth

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

February 1, 1997

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

First QC Date

September 9, 2005

Last Update Submit

August 4, 2008

Conditions

Growth Hormone DeficiencyGrowth Retardation

Outcome Measures

Primary Outcomes (7)

  • The main efficacy variable is the height SDS (SEMPE) before and after treatment.

  • The standing height of the patients is measured during the inclusion visit and at each follow-up visit.

  • The height measurements are always performed at the same time of the day by

  • use of a wallmounted device (e.g. Harpenden Stadiometer).

  • Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.

  • The body weight is measured by use of a balance scale.

  • Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

Interventions

SomatropinDRUG

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
  • All patients who have stopped during one year will be included if a signed written informed consent

You may not qualify if:

  • Endocrine disease, except well substituted hypothyroidism
  • Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Paris, France

Location

Related Publications (1)

  • David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

    PMID: 29029101DERIVED

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

February 1, 1997

Study Completion

October 1, 2006

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations

FR(1)