Growth Hormone DeficiencyPhase 4NCT00689260

Easypod United States User Trial

A Phase 4 study testing easypod in people with Growth Hormone Deficiency, run by EMD Serono at 1 site 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

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Growth Hormone Deficiency
What is being tested?: easypod
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Oct 2009
Phase: Phase 4
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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
Be willing and able to comply with the protocol for the duration of the trial
Have access to the Internet
Be able to read, speak and understand English
If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide

Who cannot join

Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
Severe illness during the previous 6 months
Active malignancy (except non-melanomatous skin malignancies)
Diabetes mellitus (type I or II)
Pregnancy or lactation
Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
Participation in any other investigational study during the duration of participation in this trial

Trial locations and contacts

1 site in 1 country.

United States1 site

US Medical Information
Rockland, Massachusetts, 02370

Other trials in United States

About this study

Official title: A Randomized, Multicenter, 3 Month Phase IV Study to Evaluate the Effect on Subject Adherence With Injection Schedule by Using the Easypod™ rhGH Delivery Device

This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhGH pen injection devices.

Conditions: Growth Hormone Deficiency
Being tested: easypod
Medical subject headings: Dwarfism, Pituitary

What participants receive

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

easypodDevice
Subjects is aware that the device records injection information that can be viewed by user
easypodDevice
Subjects is not aware that the device records injection information that can be viewed by user

Study groups in NCT00689260
Study group	Role	What they receive
1 - Log Aware	Active comparator	Dose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary. Receives: Device: easypod
2 - Log Unaware	Active comparator	Dose Log Unaware (patient is not aware that the device records their injection information) Half the subjects in the log unaware arm will complete a diary. The other half in the log unaware arm will not complete the diary. Receives: Device: easypod

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
Measured: 90 Days

Secondary outcomes (3)

Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Measured: 90 Days
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Measured: 90 Days
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Measured: 90 Days

Timeline

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

Mar 2008Oct 2009

First posted3 Jun 2008 (estimated)
Study startMar 2008
Primary completionMay 2009
Study completionOct 2009

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.
Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
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 4
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689260
Sponsor's protocol ID: 28358
Status last verified: Apr 2015
First submitted: 22 May 2008
Last updated: 15 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, 3 Month Phase IV Study to Evaluate the Effect on Subject Adherence With Injection Schedule by Using the Easypod™ rhGH Delivery Device
ClinicalTrials.gov ID: NCT00689260
Acronym / sponsor ID: 28358
Conditions: Growth Hormone Deficiency
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: EMD SeronoIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: May 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Posted 20 Jul 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

Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1 - Log Aware	Active comparator	Device: easypodDose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary.
2 - Log Unaware	Active comparator	Device: easypodDose Log Unaware (patient is not aware that the device records their injection information) Half the subjects in the log unaware arm will complete a diary. The other half in the log unaware arm will not complete the diary.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
Be willing and able to comply with the protocol for the duration of the trial
Have access to the Internet

Key exclusion criteria (7 listed)

Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
Severe illness during the previous 6 months
Active malignancy (except non-melanomatous skin malignancies)
Diabetes mellitus (type I or II)
Pregnancy or lactation

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
easypodSubjects is aware that the device records injection information that can be viewed by user	Device	1 - Log Aware
easypodSubjects is not aware that the device records injection information that can be viewed by user	Device	2 - Log Unaware

Primary outcome

Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
Time frame: 90 Days

3 secondary outcomes

Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Time frame: 90 Days
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Time frame: 90 Days
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Time frame: 90 Days

Results and safety

Results posted to the registry on 20 Jul 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
Log Aware	21	19
Log Unaware	21	21

Primary outcome: Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)

Time frame: 90 Days. Median (Full Range). Unit: Percent of injections missed

Measure	Log Aware n = 15	Log Unaware n = 20	Total n = 35
Value	20 (0 to 71.7)	19.46 (1.1 to 90.9)	20 (0 to 90.9)

Log Aware vs Log Unaware: p = 0.908, Wilcoxon (Mann-Whitney)

Population analysed: The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. Seven subjects who had damaged devices or incorrect device setting were excluded from this analysis set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1, Week 12 and Four Week Follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Log Aware	1 of 21 (4.8%)	2 of 21 (9.5%)	Not reported
Log Unaware	1 of 21 (4.8%)	5 of 21 (23.8%)	Not reported

Limitations and caveats (from the sponsor): Enrollment ended early due to slow enrollment. Only 44 enrolled of the 100 subjects needed. Of the 44 enrolled, only 35 subjects had valid device data for analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Medical Responsible, MD study director

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing easypod in people with Growth Hormone Deficiency, run by EMD Serono at 1 site 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 7 inclusion and 7 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 Jul 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?

Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log) (time frame: 90 Days). 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 NCT00689260.

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 15 May 2015.