Short Stature Born Small for Gestational Age (SGA)Phase 4NCT01859949

Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

A Phase 4 study testing Genotropin (somatropin) in people with Short Stature Born Small for Gestational Age (SGA), run by Pfizer at 19 sites in Japan.

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

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing. Read more about this study

Who is it for?: Ages 4 to 8 years
Conditions the study is for: Short Stature Born Small for Gestational Age (SGA)
What is being tested?: Genotropin (somatropin)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 19 sitesJapan
Study dates: Oct 2002to Aug 2015
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 4 to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

Who cannot join

Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
Children who have received radiotherapy or chemotherapy.
Children who have serious cardiac disease, renal disease, or hepatic disease.
Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
Children who have serious chronic disease.
Children who have malignant tumor.
Children who are allergic to m-cresol.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Japan19 sites

Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Yamanashi University Hospital
Chūō, Yamanashi, 409-3898
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558
Hiroshima City Hospital
Hiroshima, Hiroshima, 730-8518
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, 594-1101
University of Occupational and Environmental Health Hospital
Kitakyushu, Fukuoka, 807-8555
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Gunma University Hospital
Maebashi, Gunma, 371-8511
Federal Officers' Mutual Aid Association Toranomon Hospital
Minato-ku, Tokyo, 105-8470
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Hokkaido Social Service Association Obihiro Hospital
Obihiro, Hokkaido, 080-0805
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Osaka Employees' Pension Hospital
Osaka, Osaka, 553-0003
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535
Tottori University Hospital
Yonago, Tottori, 683-8504

Other trials in Japan

About this study

Official title: Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Conditions: Short Stature Born Small for Gestational Age (SGA)
Being tested: Genotropin (somatropin)
Keywords: Genotropin(somatropin), SGA, Short Stature, Long-term, Safety
Medical subject headings: Dwarfism

What participants receive

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

Genotropin (somatropin)Drug
Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients

Study groups in NCT01859949
Study group	Role	What they receive
Genotropin (somatropin)	Experimental	Not described Receives: Drug: Genotropin (somatropin)

What is being measured

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

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Month 12 (at the end of previous study) to 156

Secondary outcomes (5)

Height Velocity Standard Deviation Score (SDS) for Chronological Age
Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values of the participants age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Measured: Month 12 (at the end of previous study) to 156
Height Velocity
Height velocity is the yearly height gain
Measured: Month 12 (at the end of previous study) to 156
Height SDS for Chronological Age
Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values on the participant age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Measured: Month 12 (at the end of previous study) to 156
Height Velocity SDS for Bone Age
To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.
Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Measured: Month 12 (at the end of previous study) to 156
Height SDS for Bone Age
To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.
Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,
where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.
The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Measured: Month 12 (at the end of previous study) to 156

Timeline

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

Oct 2002Aug 2015

First posted22 May 2013 (estimated)
Study startOct 2002
Primary completionAug 2015
Study completionAug 2015

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 Short Stature Born Small for Gestational Age (SGA)Studies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859949
Sponsor's protocol ID: GENASG-0021-007
Other IDs: A6281225, 2015-004552-21, 2015
Status last verified: Mar 2016
First submitted: 17 Apr 2013
Last updated: 3 May 2016
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

Active, not recruitingPhase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Short Stature Children Born Small for Gestational Age (SGA)
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
Active, not recruitingPhase 3
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
SGA, Turner Syndrome, Noonan Syndrome, ISS
RecruitingPhase 3
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
Small for Gestational Age
RecruitingPhase 3
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
ISS, SGA

All Short Stature Born Small for Gestational Age (SGA) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002)
ClinicalTrials.gov ID: NCT01859949
Acronym / sponsor ID: GENASG-0021-007
Conditions: Short Stature Born Small for Gestational Age (SGA)
Keywords: Genotropin(somatropin), SGA, Short Stature, Long-term, Safety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 15 Mar 2016

Clinical summary

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

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Genotropin (somatropin)	Experimental	Drug: Genotropin (somatropin)

Who may qualify

Ages: 4 to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

Key exclusion criteria (7 listed)

Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment.
Children who have received radiotherapy or chemotherapy.
Children who have serious cardiac disease, renal disease, or hepatic disease.
Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism.
Children who have serious chronic 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 (somatropin)Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients	Drug	Genotropin (somatropin)

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Month 12 (at the end of previous study) to 156

5 secondary outcomes

Height Velocity Standard Deviation Score (SDS) for Chronological Age
Time frame: Month 12 (at the end of previous study) to 156
Height Velocity
Time frame: Month 12 (at the end of previous study) to 156
Height SDS for Chronological Age
Time frame: Month 12 (at the end of previous study) to 156
Height Velocity SDS for Bone Age
Time frame: Month 12 (at the end of previous study) to 156
Height SDS for Bone Age
Time frame: Month 12 (at the end of previous study) to 156

Results and safety

Results posted to the registry on 15 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose-Increasing Group	29	15
Dose-Remaining Group	32	15

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Month 12 (at the end of previous study) to 156. Number. Unit: participant

Measure	Dose-Increasing Group n = 29	Dose-Remaining Group n = 32
AE	27	31
SAE	10	5

Population analysed: Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose-Increasing Group	10 of 29 (34.5%)	27 of 29 (93.1%)	Not reported
Dose-Remainig Group	5 of 32 (15.6%)	31 of 32 (96.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Short Stature Born Small for Gestational Age (SGA)

Active, not recruitingPhase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Short Stature Children Born Small for Gestational Age (SGA)
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome
Active, not recruitingPhase 3
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
SGA, Turner Syndrome, Noonan Syndrome, ISS
RecruitingPhase 3
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
Small for Gestational Age
RecruitingPhase 3
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
ISS, SGA

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Genotropin (somatropin) in people with Short Stature Born Small for Gestational Age (SGA), run by Pfizer at 19 sites in Japan.

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 1 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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Japan. 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 15 Mar 2016). 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?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Month 12 (at the end of previous study) to 156). 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 NCT01859949.

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 3 May 2016.