Trial · NCT00174252
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
NCT00174252, Phase 3, Completed, Pfizer; results first posted 2010-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age. Trials, record NCT00174252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174252
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
- NCT number
- NCT00174252
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Fetal Growth Retardation
- Interventions
- Genotonorm (Somatropin)
- First posted
- 2005-09-15
- Last updated
- 2010-06-15
- Results first posted
- 2010-06-04
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months | 9 and 12 months | Percentage of children with serum IGF-1 \> 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined. |
| Secondary | Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 12 months | The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline". |
| Secondary | Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 24 months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline". |
| Secondary | Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Baseline, 12 and 24 months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline". |
| Secondary | Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 12 months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline". |
| Secondary | Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 24 months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline". |
| Secondary | Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Baseline, 12 and 24 months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline". |
| Secondary | Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | 12 and 24 months | Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months |
| Secondary | Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | 12 and 24 months | Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months |
| Secondary | Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 12 months | Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| OTHER_PRE_SPECIFIED | Change in Height From Baseline | Baseline, 12 and 24 months | FAS. Number of Participants Analyzed = Number of children with evaluable height data at 12 and 24 months. | centimeters (cm) | MEAN |
| PRIMARY | Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months | 9 and 12 months | The safety analysis set (SAS) was defined as all patients who received at least one dose of GH treatment. Number of Participants Analyzed = Number of children treated. | percentage of participants | NUMBER |
| SECONDARY | Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 12 months | The full analysis set (FAS) included all patients who received at least one dose of assigned treatment and had at least one subsequent rating of IGF-1. Number of Participants Analyzed = Number of children with IGF-1 \< = 2 SD at 9 or 12 months with evaluable height SD CA data at 12 months. | SD for CA | MEAN |
| SECONDARY | Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 24 months | FAS. Number of Participants Analyzed = Number of children with IGF-1 \< = 2 SD at 9 or 12 months with evaluable height SD CA data at 24 months. | SD for CA | MEAN |
| SECONDARY | Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Baseline, 12 and 24 months | FAS. Number of Participants Analyzed = Number of children with IGF-1 \> 2 SD at 9 and 12 months with evaluable Height SD CA data at 12 and 24 months. | SD for BA | MEAN |
| SECONDARY | Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 12 months | FAS. Number of Participants Analyzed = Number of children with IGF-1 \< = 2 SD at 9 or 12 months with evaluable height SD BA data at 12 months. | SD for BA | MEAN |
| SECONDARY | Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Baseline, 24 months | FAS. Number of Participants Analyzed = Number of children with IGF-1 \< = 2 SD at 9 or 12 months with evaluable height SD BA data at 24 months. | Height in SD | MEAN |
| SECONDARY | Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Baseline, 12 and 24 months | FAS. Number of Participants Analyzed = Number of children with IGF-1 \> 2 SD at 9 or 12 months with evaluable height SD BA data at 12 and 12 months. | SD for BA | MEAN |
| OTHER_PRE_SPECIFIED | Growth Rate at 12 and 24 Months | 12 and 24 months | FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable growth rate data at 12 and 24 months. | cm/year | MEAN |
| SECONDARY | Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | 12 and 24 months | FAS. Number of Participants Analyzed = Number of children with IGF-1 \< = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 12 months. n = Number of children with IGF-1 \< = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 24 months. | SD for CA | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Height From Baseline | Genotonorm | 12 Months | 9.0 | Standard Deviation 1.3 | centimeters (cm) |
| Change in Height From Baseline | Genotonorm | 24 Months | 16.4 | Standard Deviation 2.2 | centimeters (cm) |
| Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months | Genotonorm | No | 86.0 | percentage of participants | |
| Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months | Genotonorm | Yes | 14.0 | percentage of participants | |
| Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Genotonorm | 0.81 | Standard Deviation 0.26 | SD for CA | |
| Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Genotonorm | 1.24 | Standard Deviation 0.48 | SD for CA | |
| Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Genotonorm | 12 Months | 1.13 | Standard Deviation 0.35 | SD for BA |
| Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Genotonorm | 24 Months | 1.53 | Standard Deviation 0.20 | SD for BA |
| Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Genotonorm | 0.44 | Standard Deviation 1.34 | SD for BA | |
| Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Genotonorm | 0.12 | Standard Deviation 1.86 | Height in SD |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genotonorm | 57 | |
| Overall Study | COMPLETED | Genotonorm | 55 | |
| Overall Study | NOT COMPLETED | Genotonorm | 2 |
Source ClinicalTrials.gov
Adverse events57
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 | Microcytosis | Blood and lymphatic system disorders | Genotonorm | 1 | 57 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | Genotonorm | 1 | 57 | |
| other | Conjunctivitis | Eye disorders | Genotonorm | 1 | 57 | |
| other | Conjunctivitis allergic | Eye disorders | Genotonorm | 1 | 57 | |
| other | Eyelid oedema | Eye disorders | Genotonorm | 1 | 57 | |
| other | Constipation | Gastrointestinal disorders | Genotonorm | 4 | 57 | |
| other | Diarrhoea | Gastrointestinal disorders | Genotonorm | 1 | 57 | |
| other | Fatigue | General disorders | Genotonorm | 1 | 57 | |
| other | Pain | General disorders | Genotonorm | 1 | 57 | |
| other | Pyrexia | General disorders | Genotonorm | 1 | 57 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genotonorm | ||
| Total, other adverse events | Genotonorm | 30 | 57 |
| Total, serious adverse events | Genotonorm | 6 | 57 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00174252
GET https://conductscience.org/api/trials/v1/NCT00174252/registered?page=2