Easypod United States User Trial

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Brief Title

Easypod United States User Trial

Official Title

A Randomized, Multicenter, 3 Month Phase IV Study to Evaluate the Effect on Subject Adherence With Injection Schedule by Using the Easypod™ rhGH Delivery Device

Brief Summary

      This study will help to determine whether an injection log on a recombinant human growth
      hormone (rhGH) delivery device improves subjects' adherence with injection schedules.
      Adherence will be compared between a group of subjects who are aware of the injection log on
      the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™
      injection log. It is the study hypothesis that subject non-adherence rate is different for
      those who are aware of the injection log capability versus those who are unaware of the
      injection log capability. Subject perception will also be evaluated by comparing the ease and
      convenience of use and subject preference for the easypod™ compared to two other rhGH pen
      injection devices.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)

Secondary Outcome

 Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices

Condition

Growth Hormone Deficiency

Intervention

easypod

Study Arms / Comparison Groups

 1 - Log Aware
Description:  Dose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary.

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

42

Start Date

March 2008

Completion Date

October 2009

Primary Completion Date

May 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Be male or female from 10 to 18 years of age, inclusive, with open epiphyses

          -  Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6
             months

          -  Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer
             Genotropin® pen injection device for at least 6 months

          -  Be willing and able to comply with the protocol for the duration of the trial

          -  Have access to the Internet

          -  Be able to read, speak and understand English

          -  If female of childbearing potential, have a negative urine pregnancy test at Screening
             and use an acceptable form of birth control during the trial, including abstinence, a
             hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with
             spermicide

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for
             click.easy® cartridge)

          -  Severe illness during the previous 6 months

          -  Active malignancy (except non-melanomatous skin malignancies)

          -  Diabetes mellitus (type I or II)

          -  Pregnancy or lactation

          -  Any medical condition that, in the opinion of the Investigator, would jeopardize the
             subject's safety following exposure to the investigational device

          -  Participation in any other investigational study during the duration of participation
             in this trial
      

Gender

All

Ages

10 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Medical Responsible, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00689260

Organization ID

28358


Responsible Party

Sponsor

Study Sponsor

EMD Serono


Study Sponsor

Medical Responsible, MD, Study Director, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany


Verification Date

April 2015