Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

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Growth hormone deficiency
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Brief Title

Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Official Title

Observational Study to Assess Ease of Use, Acceptability and Preference of Norditropin NordiFlex® With NordiFlex PenMate™ in Subjects on Prescribed Growth Hormone Therapy

Brief Summary

      This study is conducted in Europe. The aim of this study is to evaluate ease of injection of
      growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience
      and tolerability of NordiFlex PenMateâ„¢ - an automatic injection and a needle hiding device -
      is also evaluated.

Study Type

Observational

Primary Outcome

The proportion of subjects that find growth hormone injection using Norditropin Nordiflex® with NordiFlex PenMate™ very easy or easy as assessed by patient/parent questionnaire

Secondary Outcome

 Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires

Condition

Growth Hormone Disorder

Intervention

NordiFlex PenMateâ„¢

Study Arms / Comparison Groups

 PenMate device
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

84

Start Date

January 2007

Completion Date

March 2009

Primary Completion Date

March 2009

Eligibility Criteria

        Inclusion Criteria:

          -  After the physician decision has been made to use Norditropin Nordiflex® growth
             hormone therapy in accordance with the locally approved labelling, any subject is
             eligible for the study, including newly diagnosed subjects who have never received
             growth hormone therapy before and subjects who were treated with the other growth
             hormone products (with exclusion of patients who received previously Norditropin
             Nordiflex®) and need to be switched to a new product. The selection of the subjects
             will be at the discretion of the individual physician

        Exclusion Criteria:

          -  Contraindications to Norditropin® growth hormone therapy

          -  Subjects who have received Norditropin NordiFlex® prior to this study

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Global Clinical Registry (GCR, 1452), ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT01500486

Organization ID

GH-3717

Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S

Study Sponsor

Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Verification Date

November 2016