Trial · NCT00625872

Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

NCT00625872, Phase 3, Terminated, Pfizer; results first posted 2012-02-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy. Trials, record NCT00625872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00625872

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
NCT number: NCT00625872
Status: Terminated
Phases: Phase 3
Enrollment: 23 participants, actual
Lead sponsor: Pfizer
Conditions: Growth Hormone Therapy, Infant, Small for Gestational Age
Interventions: Somatropin, Somatropin
First posted: 2008-02-28
Last updated: 2012-02-29
Results first posted: 2012-02-29
Limitations and caveats: The study was prematurely discontinued, therefore not all data was powered.

Source ClinicalTrials.gov

Registered outcomes53

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Baseline and Month 6	Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Primary	Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6	Baseline and Month 6	PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Primary	Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Baseline and Month 6	PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.
Primary	Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6	Baseline and Month 6	PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.
Primary	Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Baseline and Month 6	Vmax was measured by Leonardo Jumping Platform during two-leg jump.
Primary	Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6	Baseline and Month 6	Vmax was measured by Leonardo Jumping Platform during two-leg jump.
Secondary	Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6	Baseline and Month 6	K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces\&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme \[greater than (\>) 131\], above average (116-130), average (85-115), below average (70-84), lower extreme \[less than (\<) 69\].
Secondary	Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18	Baseline, Month 12 and Month 18	K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces\&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme \[greater than (\>) 131\], above average (116-130), average (85-115), below average (70-84), lower extreme \[less than (\<) 69\].
Secondary	Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6	Baseline and Month 6	The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); "Sustained Attention", change of reaction (Flexibility); "Divided Attention", controlled reaction disposition (Go/No go) and "Vigilance". It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results.
Secondary	Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18	Baseline, Month 12 and Month 18	The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); "Sustained Attention", change of reaction (Flexibility); "Divided Attention", controlled reaction disposition (Go/No go) and "Vigilance". It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results.

1 to 10 of 53Source ClinicalTrials.gov

See all 53 registered outcomes

Outcomes53

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Baseline and Month 6	FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.	Watt/kilogram (W/kg)	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6	Baseline and Month 6	PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.	W/kg	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Baseline and Month 6	FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.	Newtons	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6	Baseline and Month 6	FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.	Units on a scale	MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18	Baseline, Month 12 and Month 18	Data were not analyzed as study was prematurely terminated due to insufficient number of participants.	Units on a scale	MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6	Baseline and Month 6	FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure and 'n' signifies participants who received the study drug and evaluated at the time point for each group respectively.	Seconds	MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18	Baseline, Month 12 and Month 18	Data were not analyzed as study was prematurely terminated due to insufficient number of participants.	Seconds	MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6	Baseline and Month 6	FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.	Units on a scale	MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18	Baseline, Month 12 and Month 18	Data were not analyzed as study was prematurely terminated due to insufficient number of participants.	Units on a scale	MEAN
SECONDARY	Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18	Baseline, Month 6, Month 12 and Month 18	Data were not analyzed as study was prematurely terminated due to insufficient number of participants.	Units on a scale	MEAN

1 to 10 of 53Source ClinicalTrials.gov

See all 53 outcomes

Results by group152

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Somatropin		-0.15	Standard Error 1.01	Watt/kilogram (W/kg)
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Control Arm		0.28	Standard Error 0.51	Watt/kilogram (W/kg)
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6	Somatropin		-1.02	Standard Error 0.43	W/kg
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6	Control Arm		0.59	Standard Error 0.27	W/kg
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Somatropin		-0.70	Standard Error 0.62	Newtons
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6	Control Arm		-0.55	Standard Error 0.29	Newtons
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6	Somatropin	Baseline (Sequential Processing)	25.7	Standard Deviation 8.35	Units on a scale
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6	Control Arm	Baseline (Sequential Processing)	28.5	Standard Deviation 8.33	Units on a scale
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6	Somatropin	Change at Month 6 (Sequential Processing)	2.6	Standard Deviation 5.82	Units on a scale
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6	Control Arm	Change at Month 6 (Sequential Processing)	-1.9	Standard Deviation 4.15	Units on a scale

1 to 10 of 152Source ClinicalTrials.gov

See all 152 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Somatropin	12
Overall Study	STARTED	Control Arm	11
Overall Study	Treated	Somatropin	12
Overall Study	Treated	Control Arm	10
Overall Study	COMPLETED	Somatropin	8
Overall Study	COMPLETED	Control Arm	5
Overall Study	NOT COMPLETED	Somatropin	4
Overall Study	NOT COMPLETED	Control Arm	6

Source ClinicalTrials.gov

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cryptorchism	Congenital, familial and genetic disorders	Somatropin	1	12
other	Cryptorchism	Congenital, familial and genetic disorders	Control Arm	0	11
other	Hypothyroidism	Endocrine disorders	Somatropin	1	12
other	Hypothyroidism	Endocrine disorders	Control Arm	0	11
other	Conjunctivitis	Eye disorders	Somatropin	0	12
other	Conjunctivitis	Eye disorders	Control Arm	1	11
other	Eyelid oedema	Eye disorders	Somatropin	1	12
other	Eyelid oedema	Eye disorders	Control Arm	0	11
other	Abdominal pain	Gastrointestinal disorders	Somatropin	1	12
other	Abdominal pain	Gastrointestinal disorders	Control Arm	0	11

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Somatropin
Total, all-cause mortality	Control Arm
Total, other adverse events	Somatropin	10	12
Total, other adverse events	Control Arm	7	11
Total, serious adverse events	Somatropin	0	12
Total, serious adverse events	Control Arm	0	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Somatropin vs Control Arm: serious adverse events

Source Trial comparisons

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Go/No-Go Task	Secondary outcome	ConductCognition
Simple Reaction Time	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00625872

GET https://conductscience.org/api/trials/v1/NCT00625872/registered?page=2

API reference For AI assistants