NCT01543880

Brief Summary

This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
752

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2003

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

July 1, 2003

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

10.4 years

First QC Date

February 28, 2012

Last Update Submit

April 28, 2015

Conditions

Growth Hormone DisorderAdult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Up to 10 years

Secondary Outcomes (3)

  • BMI (Body Mass Index)

    Up to 10 years

  • HbA1c change

    Up to 10 years

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

    Up to 10 years

Study Arms (1)

Users of somatropin

Drug: somatropin

Interventions

somatropinDRUG

Prescribed at the discretion of the treating physician according to product labelling

Users of somatropin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults in need of somatropin or current users

You may qualify if:

  • In need of somatropin or current user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mainz, 55127, Germany

Location

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

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

July 1, 2003

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

DE(1)