Trial · NCT00627523
Genotropin Treatment In Very Young Children Born Small For Gestational Age
NCT00627523, Phase 3, Completed, Pfizer; results first posted 2014-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Genotropin Treatment In Very Young Children Born Small For Gestational Age. Trials, record NCT00627523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00627523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genotropin Treatment In Very Young Children Born Small For Gestational Age
- NCT number
- NCT00627523
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 43 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Infant, Small for Gestational Age
- Interventions
- Genotropin (PN-180,307) Somatropin, Control-no treatment
- First posted
- 2008-03-03
- Last updated
- 2014-11-04
- Other registries' IDs
- eudract:2007-003949-32
- Results first posted
- 2014-09-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. | Baseline and Month 24 | Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. |
| Secondary | Change From Baseline in Growth Velocity SDS at Month 24. | Baseline and Month 24 | The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender. |
| Secondary | Change From Baseline in Height SDS at Month 12. | Baseline and Month 12 | Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender. |
| Secondary | Change From Baseline in Growth Velocity SDS at Month 12. | Baseline and Month 12 | The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender. |
| Secondary | Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. | Baseline and Month 12 | The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance. |
| Secondary | Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. | Baseline and Month 12 | BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance. |
| Secondary | Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Months 3, 6, 12, 18 and 24 | Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender. |
| Secondary | Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Baseline, Months 3, 6, 12, 18 and 24. | Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender. |
| Secondary | Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. | Baseline, Months 3, 6, 12, 18, and 24 | Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values. |
| Secondary | Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. | Baseline, Months 3, 6, 12, 18, and 24 | Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height\[m\])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values. |
Source ClinicalTrials.gov
Outcomes10
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 Height Standard Deviation Score (SDS) at Month 24. | Baseline and Month 24 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | SDS | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Growth Velocity SDS at Month 24. | Baseline and Month 24 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | SDS | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Height SDS at Month 12. | Baseline and Month 12 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | SDS | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Growth Velocity SDS at Month 12. | Baseline and Month 12 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis. | SDS | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. | Baseline and Month 12 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12. | Baseline and Month 12 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Months 3, 6, 12, 18 and 24 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | SDS | MEAN |
| SECONDARY | Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24. | Baseline, Months 3, 6, 12, 18 and 24. | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | SDS | MEAN |
| SECONDARY | Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24. | Baseline, Months 3, 6, 12, 18, and 24 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Kg | MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24. | Baseline, Months 3, 6, 12, 18, and 24 | Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis. | Kg/m2 | MEAN |
Source ClinicalTrials.gov
Results by group52
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 Height Standard Deviation Score (SDS) at Month 24. | Genotropin® | 1.63 | Standard Error 0.13 | SDS | |
| Change From Baseline in Height Standard Deviation Score (SDS) at Month 24. | Control | 0.43 | Standard Error 0.13 | SDS | |
| Change From Baseline in Growth Velocity SDS at Month 24. | Genotropin® | 0.74 | Standard Error 0.57 | SDS | |
| Change From Baseline in Growth Velocity SDS at Month 24. | Control | -0.03 | Standard Error 0.57 | SDS | |
| Change From Baseline in Height SDS at Month 12. | Genotropin® | 1.03 | Standard Error 0.12 | SDS | |
| Change From Baseline in Height SDS at Month 12. | Control | 0.14 | Standard Error 0.12 | SDS | |
| Change From Baseline in Growth Velocity SDS at Month 12. | Genotropin® | 1.65 | Standard Error 0.56 | SDS | |
| Change From Baseline in Growth Velocity SDS at Month 12. | Control | -1.59 | Standard Error 0.56 | SDS | |
| Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. | Genotropin® | 10.97 | Standard Error 5.34 | Units on a scale | |
| Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12. | Control | 8.55 | Standard Error 4.74 | Units on a scale |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genotropin® | 21 | |
| Overall Study | STARTED | Control | 22 | |
| Overall Study | COMPLETED | Genotropin® | 19 | |
| Overall Study | COMPLETED | Control | 20 | |
| Overall Study | NOT COMPLETED | Genotropin® | 2 | |
| Overall Study | NOT COMPLETED | Control | 2 |
Source ClinicalTrials.gov
Adverse events146
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 | Events |
|---|---|---|---|---|---|---|
| other | Ear disorder | Ear and labyrinth disorders | Genotropin® | 1 | 21 | |
| other | Ear disorder | Ear and labyrinth disorders | Control | 0 | 22 | |
| other | Tympanic membrane disorder | Ear and labyrinth disorders | Genotropin® | 1 | 21 | |
| other | Tympanic membrane disorder | Ear and labyrinth disorders | Control | 0 | 22 | |
| other | Conjunctivitis | Eye disorders | Genotropin® | 3 | 21 | |
| other | Conjunctivitis | Eye disorders | Control | 2 | 22 | |
| other | Abdominal pain | Gastrointestinal disorders | Genotropin® | 2 | 21 | |
| other | Abdominal pain | Gastrointestinal disorders | Control | 0 | 22 | |
| other | Constipation | Gastrointestinal disorders | Genotropin® | 1 | 21 | |
| other | Constipation | Gastrointestinal disorders | Control | 1 | 22 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genotropin® | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Genotropin® | 21 | 21 |
| Total, other adverse events | Control | 18 | 22 |
| Total, serious adverse events | Genotropin® | 6 | 21 |
| Total, serious adverse events | Control | 2 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26501737 | DERIVED |
Source PubMed
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 |
|---|
| Genotropin® vs Control: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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/NCT00627523
GET https://conductscience.org/api/trials/v1/NCT00627523/results?page=2