Trial · NCT00163215
Growth Retardation In Children With Special Pathological Conditions Or Disease
NCT00163215, Phase 3, Completed, Pfizer; results first posted 2012-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Growth Retardation In Children With Special Pathological Conditions Or Disease. Trials, record NCT00163215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00163215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Growth Retardation In Children With Special Pathological Conditions Or Disease
- NCT number
- NCT00163215
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 46 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Endocrine System Diseases
- Interventions
- Somatropin
- First posted
- 2005-09-13
- Last updated
- 2012-12-19
- Results first posted
- 2012-12-19
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population | Baseline, Month 36 | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population. |
| Primary | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population | Baseline, Month 36 | Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population. |
| Secondary | Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Baseline, Month 12, Month 24, Month 36 | Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y\[x-1\] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y\[x-1\]) and height recorded at Yx (AGR Yx = \[height Yx-height Y{x-1}\] / (\[date of Yx - date of Y{x-1}\] /365.25). |
| Secondary | Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | Baseline, Month 12, Month 24, Month 36 | Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y\[x-1\] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y\[x-1\]) and height recorded at Yx (AGR Yx = \[height Yx-height Y{x-1}\] / (\[date of Yx - date of Y{x-1}\] /365.25). |
| Secondary | Height | Baseline, Month 12, Month 24, Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. |
| Secondary | Change From Baseline in Height at Month 12, Month 24 and Month 36 | Baseline, Month 12, Month 24, Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. |
| Secondary | Mean Height Standard Deviation Score (SDS) for Chronological Age (CA) | Baseline, Month 12, Month 24, Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar the participant was to the reference population. |
| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36 | Baseline, Month 12, Month 24, Month 36 | Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height - reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement - Date of birth)/365.25\*12. SDS indicates how similar the participant was to the reference population. |
| Secondary | Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | Baseline, Month 12, Month 24, Month 36 | Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. |
| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36 | Baseline, Month 12, Month 24, Month 36 | Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height-reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population | Baseline, Month 36 | Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | SDS | MEAN |
| PRIMARY | Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population | Baseline, Month 36 | Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | SDS | MEAN |
| SECONDARY | Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | centimeter per year (cm/year) | MEAN |
| SECONDARY | Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | Baseline, Month 12, Month 24, Month 36 | PP analysis set included all participants in the ITT set without a major protocol violation. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | cm/year | MEAN |
| SECONDARY | Height | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here n signifies those participants evaluated at that time point. | cm | MEAN |
| SECONDARY | Change From Baseline in Height at Month 12, Month 24 and Month 36 | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | cm | MEAN |
| SECONDARY | Mean Height Standard Deviation Score (SDS) for Chronological Age (CA) | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here n signifies those participants evaluated at that time point. | SDS | MEAN |
| SECONDARY | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36 | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | SDS | MEAN |
| SECONDARY | Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | SDS | MEAN |
| SECONDARY | Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36 | Baseline, Month 12, Month 24, Month 36 | ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants evaluated at that time point. | SDS | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group55
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 Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population | Genotonorm | Baseline (n = 42) | -1.29 | Standard Deviation 1.79 | SDS |
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population | Genotonorm | Change at Month 36 (n = 26) | 2.36 | Standard Deviation 1.98 | SDS |
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population | Genotonorm | Baseline (n = 14) | -1.98 | Standard Deviation 1.06 | SDS |
| Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population | Genotonorm | Change at Month 36 (n = 12) | 2.70 | Standard Deviation 2.02 | SDS |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Genotonorm | Baseline (n = 42) | 4.5 | Standard Deviation 1.8 | centimeter per year (cm/year) |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Genotonorm | Change at Month 12 (n = 36) | 3.3 | Standard Deviation 2.9 | centimeter per year (cm/year) |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Genotonorm | Change at Month 24 (n = 35) | 2.5 | Standard Deviation 2.7 | centimeter per year (cm/year) |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population | Genotonorm | Change at Month 36 (n = 26) | 2.0 | Standard Deviation 2.0 | centimeter per year (cm/year) |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | Genotonorm | Baseline (n = 14) | 4.0 | Standard Deviation 1.0 | cm/year |
| Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population | Genotonorm | Change at Month 12 (n = 14) | 4.0 | Standard Deviation 1.0 | cm/year |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 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 | 46 | |
| Overall Study | COMPLETED | Genotonorm | 31 | |
| Overall Study | NOT COMPLETED | Genotonorm | 15 |
Source ClinicalTrials.gov
Adverse events42
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 | Diarrhoea | Gastrointestinal disorders | Genotonorm | 2 | 46 | |
| other | Bronchopulmonary aspergillosis allergic | Infections and infestations | Genotonorm | 1 | 46 | |
| other | Influenza | Infections and infestations | Genotonorm | 1 | 46 | |
| other | Laryngitis | Infections and infestations | Genotonorm | 1 | 46 | |
| other | Nasopharyngitis | Infections and infestations | Genotonorm | 1 | 46 | |
| other | Oral herpes | Infections and infestations | Genotonorm | 2 | 46 | |
| other | Tracheitis | Infections and infestations | Genotonorm | 1 | 46 | |
| other | Joint injury | Injury, poisoning and procedural complications | Genotonorm | 1 | 46 | |
| other | Ligament sprain | Injury, poisoning and procedural complications | Genotonorm | 1 | 46 | |
| other | Ammonia increased | Investigations | Genotonorm | 1 | 46 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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 | 21 | 46 |
| Total, serious adverse events | Genotonorm | 4 | 46 |
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/NCT00163215
GET https://conductscience.org/api/trials/v1/NCT00163215/results?page=2