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French National Registry of Children Born Small for Gestational Age Treated With Somatropin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01578135
First received: April 13, 2012
Last updated: February 14, 2013
Last verified: December 2012
History of Changes
  Purpose

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II).


Condition Intervention
Growth Disorder
Small for Gestational Age
 Drug: No treatment given

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Growth in height [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure: Systolic and diastolic [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ] [ Designated as safety issue: No ]
  • Bone age [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ] [ Designated as safety issue: No ]
  • Insulin-Like Growth Factor 1 (IGF-1) [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2005
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I Drug: No treatment given
Patients are to fill in a questionnaire at inclusion in registry
Phase II Drug: No treatment given
Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Phase I: All patients born SGA treated with Norditropin® SimpleXx® (somatropin) whether they were previously treated with another growth hormone for this indication or not from the 29th of April 2005 until 29th of April 2010.

Phase II: Sub-population randomly selected (every 5th patient being included in registry in study phase I)

Criteria

Inclusion Criteria:

  • Born small for gestational age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578135

Locations
France
Paris La Défense, France, 92936
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Delphine Jaquet, MD Novo Nordisk France
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01578135     History of Changes
Other Study ID Numbers: GHSGA-1757
Study First Received: April 13, 2012
Last Updated: February 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013