Small for Gestational AgeNCT00793325

Long Term Use of Somatropin in Patients Small for Gestational Age

An observational study of Small for Gestational Age, run by Pfizer.

Completed

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

Trial summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. Read more about this study

Who is it for?: Any age
Conditions the study is for: Small for Gestational Age
What is being tested?: Somatropin
How many people: 920 participants
Where: No sites listed yet
Study dates: Feb 2009to Dec 2012
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).

Who may be able to join

Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.

Who cannot join

Patients not administered Somatropin (Genotropin®).

About this study

Official title: Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)

Read the detailed description

All the patients whom an investigator prescribes the first Genotropin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions: Small for Gestational Age
Being tested: Somatropin

What participants receive

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

SomatropinDrug
Also called Genotropin
Genotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription.
Frequency and duration are according to Package Insert as follows. " Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route."

Study groups in NCT00793325
Study group	Role	What they receive
Somatropin		Patients administered Somatropin. Receives: Drug: Somatropin

What is being measured

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

Number of Participants With Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.
Measured: Up to 3 years
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.
To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.
To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications
To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.
To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.
To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).
To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.
Measured: Up to 3 years
Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.
Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.
Measured: Up to 3 years
Change in Height SD Score for Calendar Age.
The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.
Measured: Up to 3 years

Timeline

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

Feb 2009Dec 2012

First posted19 Nov 2008 (estimated)
Study startFeb 2009
Primary completionDec 2012
Study completionDec 2012

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 Small for Gestational AgeStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 920 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00793325
Sponsor's protocol ID: A6281292
Status last verified: Dec 2013
First submitted: 17 Nov 2008
Last updated: 6 Feb 2014
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?

Official record

RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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 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)

All Small for Gestational Age trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT00793325
Acronym / sponsor ID: A6281292
Conditions: Small for Gestational Age
Study type: Observational
Recruitment status: Completed
Enrolment: 920 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 6 Feb 2014

Clinical summary

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

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Somatropin	–	Drug: SomatropinPatients administered Somatropin.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).

Key inclusion criteria (1 listed)

Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.

Key exclusion criteria (1 listed)

Patients not administered Somatropin (Genotropin®).

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
SomatropinAlso: GenotropinGenotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route."	Drug	Somatropin

Primary outcome

Number of Participants With Treatment Related Adverse Events.
Time frame: Up to 3 years
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Time frame: Up to 3 years
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.
Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.
Time frame: Up to 3 years
To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
Time frame: Up to 3 years
To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.
Time frame: Up to 3 years
To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
Time frame: Up to 3 years
To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications
Time frame: Up to 3 years
To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.
Time frame: Up to 3 years
To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.
Time frame: Up to 3 years
To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).
Time frame: Up to 3 years
To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.
Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.
Time frame: Up to 3 years
Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.
Change in Height SD Score for Calendar Age.
Time frame: Up to 3 years
The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.

Results and safety

Results posted to the registry on 6 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Somatropin for Small-for-gestational Age	909	890

Primary outcome: Number of Participants With Treatment Related Adverse Events.

Time frame: Up to 3 years. Number. Unit: participants

Measure	Somatropin for Small-for-gestational Age n = 890
Value	44

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Primary outcome: Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

Time frame: Up to 3 years. Number. Unit: events

Measure	Somatropin for Small-for-gestational Age n = 890
Value	26

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Primary outcome: Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.

Time frame: Up to 3 years. Number. Unit: participants

Measure	<15 Years n = 884	>=15 Years n = 6
Value	44	0

<15 Years vs >=15 Years: p =0.575, Chi-squared

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Primary outcome: Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

Time frame: Up to 3 years. Number. Unit: participants

Measure	Male n = 467	Female n = 423
Value	19	25

Male vs Female: p =0.206, Chi-squared

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somatropin for Small-for-gestational Age	8 of 890 (0.9%)	36 of 890 (4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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 Small for Gestational Age

RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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 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)

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

Questions about this trial

What is this clinical trial studying?

An observational study of Small for Gestational Age, run by Pfizer.

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 1 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2014). 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 Treatment Related Adverse Events. (time frame: Up to 3 years). The study lists 12 primary outcomes in all. 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 NCT00793325.

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 6 Feb 2014.