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

May 15, 2012 updated by: Pfizer

A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno - mesto, Czech Republic, 61300
        • Fakultni nemocnice Brno
      • Olomouc, Czech Republic, 775 20
        • Fakultni Nemocnice Olomouc
      • Praha 2, Czech Republic, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 5, Czech Republic, 150 06
        • Fakultni nemocnice v Motole
  • Germany
      • Datteln, Germany, 45711
        • Vestische Kinder- und Jugendklinik Datteln
      • Erlangen, Germany, 91054
        • Universitaetsklinik fuer Kinder und Jugendliche
      • Frankfurt-Niederrad, Germany, 60528
        • Praxis fuer paediatrische Endokrinologie
      • Gauting, Germany, 82131
        • Privatpraxis
      • Oldenburg, Germany, 26122
        • Privatpraxis
  • Netherlands
      • Den Haag, Netherlands
        • Juliana Kinderziekenhuis / Endocrinologie
      • Rotterdam, Netherlands, 3015 GD
        • Sophia Kinderziekenhuis
  • Slovakia
      • Bratislava, Slovakia, 833 40
        • Detska fakultna nemonica s poliklinikou, II. Detska klinika
      • Lubochna, Slovakia, 034 91
        • Narodny Endokrinologicky a diabetologicky ustav
  • Sweden
      • Goteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)
      • Goteborg, Sweden, 416 85
        • Drottning Silvias barn- och ungdomssjukhus, SU/Ostra
      • Linkoping, Sweden, 581 85
        • Barn och Ungdomsmedicinkliniken
      • Umea, Sweden, 901 85
        • Barnmedicinkliniken N
  • Turkey
    • Ankara
      • Sihhiye, Ankara, Turkey, 06100
        • Ankara University Medical Faculty Department of Internal Diseases
    • Istanbul
      • Capa, Istanbul, Turkey, 34390
        • Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases
  • United Kingdom
      • Glasgow, United Kingdom, G3 8SJ
        • Royal Hospital for Sick Children
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust, Hope Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Mark VII/Current pen
Subject will use Mark VII pen for 2 months followed by Current pen for 2 months
Device: Genotropin Pen
Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
Device: MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Device: Genotropin Pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
OTHER: Current pen/Mark VII
Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
Device: Genotropin Pen
Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
Device: MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Device: Genotropin Pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Month 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
Month 4
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
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.
Month 4
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®
Time Frame: Month 4
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.
Month 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
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.
Month 4
Ease of Use of Each Injection Pen
Time Frame: Month 2 and Month 4
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).
Month 2 and Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6281297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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