Small for Gestational Age (SGA)NCT01897766

Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

An observational study of Small for Gestational Age (SGA), 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 Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA). Read more about this study

Who is it for?: Ages 2 to 20 years
Conditions the study is for: Small for Gestational Age (SGA)
What is being tested?: Somatropin
How many people: 482 participants
Where: No sites listed yet
Study dates: 5 Sep 2013to 7 Jun 2017
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 2 to 20 years
All sexes
No healthy volunteers
Child, Adult

Study population: * A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age (<or=-2 SD)). * A patient who is SGA and older than 3 years. * A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the mean for chronologic age).

Who may be able to join

A patient who was administered Somatropin (Genotropin).

Who cannot join

N/A.

About this study

Official title: AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)

The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

Read the detailed description

All the patients whom an investigator prescribes 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 (SGA)
Being tested: Somatropin
Keywords: Genotropin, Somatropin, Long Term Follow-Up, Special Investigation, Small for Gestational Age, SGA

What participants receive

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

SomatropinDrug
Also called Genotropin
0.23 mg to 0.48 mg/kg/week

Study groups in NCT01897766
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 Adverse Drug Reaction (ADR)
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.
Measured: Approximately 11.58 years
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 1
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 2
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 3
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 4
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 5
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 6
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 7
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 10
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 1
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 2
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 3
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 4
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 5
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 6
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 7
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 9
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Measured: Baseline, Year 10

Secondary outcomes (2)

Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height
Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.
Measured: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.
Measured: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years

Timeline

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

5 Sep 20137 Jun 2017

First posted12 Jul 2013 (estimated)
Study start5 Sep 2013
Primary completion28 Feb 2017
Study completion7 Jun 2017

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 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01897766
Sponsor's protocol ID: A6281314
Status last verified: Aug 2023
First submitted: 9 Jul 2013
Last updated: 25 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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

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)
Not yet recruitingPhase 3
A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
Small for Gestational Age
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

All Small for Gestational Age (SGA) trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
ClinicalTrials.gov ID: NCT01897766
Acronym / sponsor ID: A6281314
Conditions: Small for Gestational Age (SGA)
Keywords: Genotropin, Somatropin, Long Term Follow-Up, Special Investigation, Small for Gestational Age, SGA
Study type: Observational
Recruitment status: Completed
Enrolment: 482 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 5 Sep 2013 (actual)
Primary completion: 28 Feb 2017 (actual)
Study completion: 7 Jun 2017 (actual)
First posted: 12 Jul 2013 (estimated)
Results: Posted 11 Feb 2020

Clinical summary

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

The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Somatropin	–	Drug: SomatropinPatients administered Somatropin.

Who may qualify

Ages: 2 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: * A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age (<or=-2 SD)). * A patient who is SGA and older than 3 years. * A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the mean for chronologic age).

Key inclusion criteria (1 listed)

A patient who was administered Somatropin (Genotropin).

Key exclusion criteria (1 listed)

N/A.

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: Genotropin0.23 mg to 0.48 mg/kg/week	Drug	Somatropin

Primary outcome

Number of Participants With Adverse Drug Reaction (ADR)
Time frame: Approximately 11.58 years
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
Time frame: Baseline, Year 1
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Time frame: Baseline, Year 2
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Time frame: Baseline, Year 3
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Time frame: Baseline, Year 4
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Time frame: Baseline, Year 5
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Time frame: Baseline, Year 6
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Time frame: Baseline, Year 7
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Time frame: Baseline, Year 10
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
Time frame: Baseline, Year 1
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Time frame: Baseline, Year 2
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Time frame: Baseline, Year 3
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Time frame: Baseline, Year 4
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Time frame: Baseline, Year 5
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Time frame: Baseline, Year 6
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Time frame: Baseline, Year 7
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
Time frame: Baseline, Year 9
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Time frame: Baseline, Year 10
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. 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. SD score indicates how similar participant was to reference population.

2 secondary outcomes

Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height
Time frame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline
Time frame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years

Results and safety

Results posted to the registry on 11 Feb 2020, 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 [Somatropin (Genetical Recombination)]	482	482

Primary outcome: Number of Participants With Adverse Drug Reaction (ADR)

Time frame: Approximately 11.58 years. Number. Unit: Participants

Measure	Genotropin [Somatropin (Genetical Recombination)] n = 482
ADR	24
SADR	4

Population analysed: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin.

Primary outcome: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1

Time frame: Baseline, Year 1. Mean (Standard Deviation). Unit: SD score

Measure	Genotropin [Somatropin (Genetical Recombination)] n = 324
Value	4.1 (3.06)

Population analysed: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Primary outcome: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2

Time frame: Baseline, Year 2. Mean (Standard Deviation). Unit: SD score

Measure	Genotropin [Somatropin (Genetical Recombination)] n = 243
Value	3.0 (2.92)

Primary outcome: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3

Time frame: Baseline, Year 3. Mean (Standard Deviation). Unit: SD score

Measure	Genotropin [Somatropin (Genetical Recombination)] n = 169
Value	2.5 (2.53)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 11.58 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Genotropin [Somatropin (Genetical Recombination)]	32 of 482 (6.6%)	105 of 482 (21.8%)	1 of 482

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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

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 (SGA), 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 25 Sep 2023. 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 11 Feb 2020). 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 Drug Reaction (ADR) (time frame: Approximately 11.58 years). The study lists 18 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 NCT01897766.

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 25 Sep 2023.