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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Genotropin Study Assessing Use of Injection Pen

NCTNCT00965484 (opens ClinicalTrials.gov in a new tab)Other idA6281291
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
136 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2009
Primary completion
Jan 2010
Completion
Jan 2010
First posted
25 Aug 2009 (estimated)
Last update posted
28 Jan 2011 (estimated)
Conditions
Growth Hormone Deficiency · Idiopathic Short Stature

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 3

    Genotropin Study Assessing Use of Injection Pen

    NCT00965484

    Oct 2009 to Jan 2010

Registry summary

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

Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.

Interventions

  • New Genotropin PenDevice

Arms1

  • Experimental

    Genotropin pen

    All subjects will receive genotropin pen to use for 2 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 2 months

    Registry description

    Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).

Secondary outcomes(3)

  1. Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®

    Time frame · 2 months

    Registry description

    Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).

  2. Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®

    Time frame · 2 months

    Registry description

    Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).

  3. Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®

    Time frame · 2 months

    Registry description

    Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).

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· 2 months

Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®

GroupValue (percentage of dyads)
Genotropin / Genotropin Mark VII Pen73.68
Secondary and other outcome results(3)
Secondary outcomeNumber· 2 months

Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®

GroupValue (percentage of dyads)
Genotropin / Genotropin Mark VII Pen65.15
Secondary outcomeNumber· 2 months

Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®

GroupValue (percentage of dyads)
Genotropin / Genotropin Mark VII Pen63.16
Secondary outcomeNumber· 2 months

Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®

GroupValue (percentage of dyads)
Genotropin / Genotropin Mark VII Pen59.85

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Genotropin / Genotropin Mark VII PenGenotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.–0 / 13628 / 136

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2010

Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: A multicenter, 2-month, single-arm, open-label clinical trial in patient-caregiver dyads.

Hey-Hadavi et al. 2010Clinical therapeuticscited by 19

PMID 21118739DOI 10.1016/j.clinthera.2010.11.007PUB-21118739

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 8 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 8-18 years * Using genotropin pen for at least 3 months prior to study enrollment * Compliance with genotropin treatment Exclusion Criteria: * Medical conditions that can affect participation in study * Insufficient command of English language to understand questionnaire * Using other growth hormone device and not Genotropin pen

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