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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 A/S
ClinicalTrials.gov Identifier:
NCT01578135
First received: April 13, 2012
Last updated: July 31, 2017
Last verified: July 2017
  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: somatropin

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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Growth in height [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ]

Secondary Outcome Measures:
  • Blood pressure: Systolic and diastolic [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ]
  • Bone age [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ]
  • Insulin-Like Growth Factor 1 (IGF-1) [ Time Frame: 6 months after inclusion into registry and then annually until adult height is reached ]

Estimated Enrollment: 400
Actual Study Start Date: March 19, 2007
Estimated Study Completion Date: April 28, 2022
Estimated Primary Completion Date: April 28, 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I Drug: somatropin
Patients are to fill in a questionnaire at inclusion in registry
Phase II Drug: somatropin
Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578135

Locations
France
Novo Nordisk Investigational Site
Paris La Défense, France, 92936
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01578135     History of Changes
Other Study ID Numbers: GHSGA-1757
Study First Received: April 13, 2012
Last Updated: July 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on August 22, 2017