Growth Hormone DeficiencyPhase 3NCT00965484

Genotropin Study Assessing Use of Injection Pen

A Phase 3 study testing New Genotropin Pen in people with Growth Hormone Deficiency and Idiopathic Short Stature, run by Pfizer at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 8 to 18 years
Conditions the study is for: Growth Hormone Deficiency, Idiopathic Short Stature
What is being tested?: New Genotropin Pen
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 25 sitesUnited States
Study dates: Oct 2009to Jan 2010
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 8 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 8-18 years
Using genotropin pen for at least 3 months prior to study enrollment
Compliance with genotropin treatment

Who cannot join

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Pfizer Investigational Site
Akron, Ohio, 44308
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21229
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Columbus, Ohio, 43205
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Florence, South Carolina, 29506
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Gainesville, Florida, 32608
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Greenwood Village, Colorado, 80111
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Kansas City, Missouri, 64108
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Memphis, Tennessee, 38105
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Morristown, New Jersey, 07962
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92123-4282
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Southaven, Mississippi, 38671
Pfizer Investigational Site
Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen

Conditions: Growth Hormone Deficiency, Idiopathic Short Stature
Being tested: New Genotropin Pen
Keywords: Genotropin Medical device Patient reported outcome
Medical subject headings: Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New Genotropin PenDevice
Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen

Study groups in NCT00965484
Study group	Role	What they receive
Genotropin pen	Experimental	All subjects will receive genotropin pen to use for 2 months. Receives: Device: New Genotropin 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) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®
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).
Measured: 2 months

Secondary outcomes (3)

Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®
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).
Measured: 2 months
Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®
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).
Measured: 2 months
Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®
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).
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Jan 2010

First posted25 Aug 2009 (estimated)
Study startOct 2009
Primary completionJan 2010
Study completionJan 2010

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00965484
Sponsor's protocol ID: A6281291
Status last verified: Apr 2010
First submitted: 21 Aug 2009
Last updated: 28 Jan 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hey-Hadavi J, Pleil A, Deeb LC, Fuqua JS, Silverman LA, Reiner B, Newfield R, Rajicic N, Wajnrajch MP, Cara JF. 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. Clin Ther. 2010 Nov;32(12):2036-47. doi: 10.1016/j.clinthera.2010.11.007.
PubMed 21118739

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure

All Growth Hormone Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen
ClinicalTrials.gov ID: NCT00965484
Acronym / sponsor ID: A6281291
Conditions: Growth Hormone Deficiency, Idiopathic Short Stature
Keywords: Genotropin Medical device Patient reported outcome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 25 Aug 2009 (estimated)
Results: Posted 23 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Genotropin pen	Experimental	Device: New Genotropin PenAll subjects will receive genotropin pen to use for 2 months.

Who may qualify

Ages: 8 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Age 8-18 years
Using genotropin pen for at least 3 months prior to study enrollment
Compliance with genotropin treatment

Key exclusion criteria (3 listed)

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

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
New Genotropin PenSubjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen	Device	Genotropin pen

Primary outcome

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
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).

3 secondary outcomes

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
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
Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®
Time frame: 2 months

Results and safety

Results posted to the registry on 23 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Genotropin / Genotropin Mark VII Pen	136	134

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage of dyads

Measure	Genotropin / Genotropin Mark VII Pen n = 133
Value	73.68 (66.20 to 81.17)

Population analysed: Full analysis set (FAS): all participants who used the new pen at least once to administer Genotropin and who completed the 2-month follow-up questionnaire. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Genotropin / Genotropin Mark VII Pen	0 of 136 (0%)	28 of 136 (20.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21118739Hey-Hadavi J, Pleil A, Deeb LC, Fuqua JS, Silverman LA, Reiner B, Newfield R, Rajicic N, Wajnrajch MP, Cara JF. 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. Clin Ther. 2010 Nov;32(12):2036-47. doi: 10.1016/j.clinthera.2010.11.007.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Growth Hormone Deficiency

RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure

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

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing New Genotropin Pen in people with Growth Hormone Deficiency and Idiopathic Short Stature, run by Pfizer at 25 sites in United States.

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 3 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 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. 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 23 Dec 2010). 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) 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). 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 NCT00965484, 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 28 Jan 2011.