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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

Short name CHOOSE

NCTNCT01112865 (opens ClinicalTrials.gov in a new tab)Other idA6281297
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
120 participants (actual)
Sponsor
Pfizer · Industry
Design
Randomized · Open label (no masking)
Countries
7 countries

Czechia, Germany, Netherlands, Slovakia, Sweden, Turkey (Türkiye), United Kingdom

Start
Aug 2010
Primary completion
Oct 2011
Completion
Oct 2011
First posted
28 Apr 2010 (estimated)
Last update posted
22 May 2012 (estimated)
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 3

    CHOOSE

    NCT01112865

    Aug 2010 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

Interventions

  • Genotropin PenDevice
  • MARK VII penDevice
  • Genotropin PenDevice
  • MARK VII penDevice

Arms2

  • Other

    Mark VII/Current pen

    Subject will use Mark VII pen for 2 months followed by Current pen for 2 months

  • Other

    Current pen/Mark VII

    Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

    Time frame · Month 4

    Registry description

    Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference.

Secondary outcomes(5)

  1. Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

    Time frame · Month 4

    Registry description

    Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference.

  2. Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®

    Time frame · Month 4

    Registry description

    Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference.

  3. Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®

    Time frame · Month 4

    Registry description

    Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference.

  4. Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen

    Time frame · Month 4

    Registry description

    Investigators were asked the following study treatment continuation question, "Which device did the participant choose for continued treatment?" Choices included the Genotropin® Pen or the new injection pen.

  5. Ease of Use of Each Injection Pen

    Time frame · Month 2 and Month 4

    Registry description

    Participants were asked the following question from Section I of the IPAQ PRO tool, "Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?" Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Month 4

Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

GroupValue (percentage of dyads, adult participants)
Entire Study Population67.23
Secondary and other outcome results(5)
Secondary outcomeNumber· Month 4

Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

GroupValue (percentage of dyads, adult participants)
Entire Study Population64.17
Secondary outcomeNumber· Month 4

Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®

GroupValue (percentage of dyads, adult participants)
Entire Study Population51.26
Secondary outcomeNumber· Month 4

Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®

GroupValue (percentage of dyads, adult participants)
Entire Study Population54.17
Secondary outcomeNumber· Month 4

Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen

GroupValue (percentage of dyads, adult participants)
Entire Study Population47.27
Secondary outcomeMean· Month 2 and Month 4

Ease of Use of Each Injection Pen

GroupValue (scores on a scale)Spread
Mark VII Pen4.50.64
Genotropin® Pen4.20.71

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Safety PopulationAll randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.–2 / 12048 / 120

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPleil AM, Darendeliler F, Dorr HG, Hutchinson K, Wollmann HA. Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naive children and adults. Med Devices (Auckl). 2014 Apr 11;7:61-71. doi: 10.2147/MDER.S59821. eCollection 2014. PMID 24748824

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age greater than or equal to 8 years. * Subjects who are starting treatment with growth hormone (Genotropin) for the first time. Exclusion Criteria: * Subjects with Prader-Willi syndrome or chronic renal insufficiency. * Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study. * Subjects with chronic systemic disorders, such as diabetes and heart disease.

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