NCT01578135

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

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

March 18, 2007

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2018

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

11.6 years

First QC Date

April 13, 2012

Last Update Submit

October 19, 2022

Conditions

Growth DisorderSmall for Gestational Age

Outcome Measures

Primary Outcomes (1)

  • Growth in height

    6 months after inclusion into registry and then annually until adult height is reached

Secondary Outcomes (3)

  • Blood pressure: Systolic and diastolic

    6 months after inclusion into registry and then annually until adult height is reached

  • Bone age

    6 months after inclusion into registry and then annually until adult height is reached

  • Insulin-Like Growth Factor 1 (IGF-1)

    6 months after inclusion into registry and then annually until adult height is reached

Study Arms (2)

Phase I

Drug: somatropin

Phase II

Drug: somatropin

Interventions

somatropinDRUG

Patients are to fill in a questionnaire at inclusion in registry

Phase I

Eligibility Criteria

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

You may qualify if:

  • Born small for gestational age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Paris La Défense, 92936, France

Location

Related Links

MeSH Terms

Conditions

Growth Disorders

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 16, 2012

Study Start

March 18, 2007

Primary Completion

October 9, 2018

Study Completion

October 9, 2018

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

FR(1)