Growth Hormone DeficiencyPhase 3CHOOSENCT01112865
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
A Phase 3 study testing Genotropin Pen and MARK VII pen in people with Growth Hormone Deficiency, run by Pfizer at 23 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Genotropin Pen and MARK VII pen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Aug 2010to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 8 years.
- Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
Germany5 sites
Vestische Kinder- und Jugendklinik Datteln
Datteln, 45711
Universitaetsklinik fuer Kinder und Jugendliche
Erlangen, 91054
Privatpraxis
Gauting, 82131
Praxis fuer paediatrische Endokrinologie
Niederrad, 60528
Privatpraxis
Oldenburg, 26122
Czechia4 sites
Fakultni Nemocnice Brno
Brno - Mesto, 61300
Fakultni nemocnice Olomouc
Olomouc, 775 20
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Fakultni nemocnice v Motole
Prague, 150 06
Sweden4 sites
Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)
Gothenburg, 413 45
Drottning Silvias barn- och ungdomssjukhus, SU/Ostra
Gothenburg, 416 85
Barn och Ungdomsmedicinkliniken
Linköping, 581 85
Barnmedicinkliniken N
Umeå, 901 85
United Kingdom4 sites
Royal Hospital for Sick Children
Glasgow, G3 8SJ
St Thomas Hospital
London, SE1 7EH
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Salford Royal NHS Foundation Trust, Hope Hospital
Salford, Manchester, M6 8HD
Netherlands2 sites
Sophia Kinderziekenhuis
Rotterdam, 3015 GD
Juliana Kinderziekenhuis / Endocrinologie
The Hague
Slovakia2 sites
Detska fakultna nemonica s poliklinikou, II. Detska klinika
Bratislava, 833 40
Narodny endokrinologicky a diabetologicky ustav
Ľubochňa, Slovakia, 034 91
Turkey (Türkiye)2 sites
Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases
Çapa, Istanbul, 34390
Ankara University Medical Faculty Department of Internal Diseases
Sihhiye, Ankara, 06100
About this study
Official title: 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.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Genotropin Pen, MARK VII pen
- Keywords
- Growth Hormone Deficiency, Somatropin, Injection Pen, Medical Device, Cross Over Study, Preference, Convenience, Children, Dyads, Adults
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotropin PenDevice
Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
MARK VII penDevice
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Genotropin PenDevice
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
MARK VII penDevice
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
| Study group | Role | What they receive |
|---|---|---|
| Mark VII/Current pen | Other | Subject will use Mark VII pen for 2 months followed by Current pen for 2 months Receives: Device: Genotropin Pen; Device: MARK VII pen |
| Current pen/Mark VII | Other | Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months Receives: Device: Genotropin Pen; Device: MARK VII pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®
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.
Measured: Month 4
Secondary outcomes (5)
Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®
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.
Measured: Month 4
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®
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.
Measured: Month 4
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®
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.
Measured: Month 4
Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen
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.
Measured: Month 4
Ease of Use of Each Injection Pen
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).
Measured: Month 2 and Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112865
- Sponsor's protocol ID
- A6281297
- Acronym
- CHOOSE
- Status last verified
- May 2012
- First submitted
- 20 Apr 2010
- Last updated
- 22 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pleil 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.
PubMed 24748824
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01112865
- Acronym / sponsor ID
- CHOOSE / A6281297
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Hormone Deficiency, Somatropin, Injection Pen, Medical Device, Cross Over Study, Preference, Convenience, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 14 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mark VII/Current pen | Other | Device: Genotropin Pen, Device: MARK VII penSubject will use Mark VII pen for 2 months followed by Current pen for 2 months |
| Current pen/Mark VII | Other | Device: Genotropin Pen, Device: MARK VII penSubject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 8 years.
- Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotropin PenPen 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/Current pen |
| MARK VII penPen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study. | Device | Mark VII/Current pen |
| Genotropin PenPen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study. | Device | Current pen/Mark VII |
| MARK VII penPen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study. | Device | Current pen/Mark VII |
Primary outcome
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.
5 secondary outcomes
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
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
Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®
Time frame: 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
Ease of Use of Each Injection Pen
Time frame: Month 2 and Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24748824Pleil 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genotropin Pen and MARK VII pen in people with Growth Hormone Deficiency, run by Pfizer at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Czechia, Sweden, United Kingdom, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2012.