Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

NCT ID: NCT00163189

Last Updated: 2024-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Hormone Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Somatropin

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Nord

Amiens, , France

Site Status

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

Annemasse, , France

Site Status

Hôpital Saint Jacques

Besançon, , France

Site Status

Groupe hospitalier Est- Hôpital Femme, Mère, Enfant

Bron, , France

Site Status

Groupe hospitalier Est-Hôpital Femme, Mère, Enfant

Bron, , France

Site Status

CHU d'Estaing

Clermont-Ferrand, , France

Site Status

CHU de Grenoble, Hôpital Couple enfant.

Grenoble, , France

Site Status

CHU Timone Enfants

Marseille, , France

Site Status

Hôpital Arnaud De Villeneuve

Montpellier, , France

Site Status

CHU de Nantes, Hôpital Mère Enfant

Nantes, , France

Site Status

Hôpital Lenval

Nice, , France

Site Status

Hôpital Robert Debré

Paris, , France

Site Status

Hôpital Armand Trousseau

Paris, , France

Site Status

Groupe Hospitalier Necker - Enfants Malades

Paris, , France

Site Status

Centre de Perharidy

Roscoff, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

Service de Pédiatrie- Centre Hospitalier Intercommunal

Saint-Germain-en-Laye, , France

Site Status

Hôpital des Enfants

Toulouse, , France

Site Status

CHU Tours - Centre Pediatrique Gatien de Cocheville

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30910221 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-002992-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A6281271

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.