Trial · NCT00191165
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
NCT00191165, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency. Trials, record NCT00191165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00191165
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
- NCT number
- NCT00191165
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Growth Hormone Deficiency
- Interventions
- Somatropin, Somatropin
- First posted
- 2005-09-19
- Last updated
- 2009-06-10
- Results first posted
- 2009-06-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint | 12-Months | Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient's height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD. |
| Secondary | Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) | Baseline, 12-Months, 24-Months | This was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient's height and then dividing this value by the age-and-gender-matched population height SD. |
| Secondary | Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint | 24 Months | Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient's height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint | 12-Months | All enrolled participants with baseline and 12-month height measurements. | standard deviation score | MEAN |
| SECONDARY | Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) | Baseline, 12-Months, 24-Months | All enrolled participants with at least one post-baseline height measurement, using last observation available prior to 12-month and 24-month visits respectively, if 12-month or 24-month height was not available. | standard deviation score | LEAST_SQUARES_MEAN |
| SECONDARY | Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint | 24 Months | All enrolled participants with at least one post-baseline height velocity measurement, using the last observation available prior to the 24-month visit if the 24-month height velocity was not available. | standard deviation score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint | High Dose Somatropin | 1.83 | Standard Deviation 0.91 | standard deviation score | |
| Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint | Label Dose Somatropin | 1.38 | Standard Deviation 1.41 | standard deviation score | |
| Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) | High Dose Somatropin | 12-Month Height SDS Change (N=14, N=12) | 0.49 | Standard Error 0.12 | standard deviation score |
| Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) | Label Dose Somatropin | 12-Month Height SDS Change (N=14, N=12) | 0.34 | Standard Error 0.13 | standard deviation score |
| Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) | High Dose Somatropin | 24-Month Height SDS Change (N=13, N=11) | 0.88 | Standard Error 0.17 | standard deviation score |
| Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) | Label Dose Somatropin | 24-Month Height SDS Change (N=13, N=11) | 0.40 | Standard Error 0.18 | standard deviation score |
| Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint | High Dose Somatropin | 2.58 | Standard Deviation 1.86 | standard deviation score | |
| Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint | Label Dose Somatropin | 1.45 | Standard Deviation 1.06 | standard deviation score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose Somatropin | 14 | |
| Overall Study | STARTED | Label Dose Somatropin | 13 | |
| Overall Study | COMPLETED | High Dose Somatropin | 12 | |
| Overall Study | COMPLETED | Label Dose Somatropin | 11 | |
| Overall Study | NOT COMPLETED | High Dose Somatropin | 2 | |
| Overall Study | NOT COMPLETED | Label Dose Somatropin | 2 |
Source ClinicalTrials.gov
Adverse events54
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 | Anaemia | Blood and lymphatic system disorders | High Dose Somatropin | 1 | 14 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Label Dose Somatropin | 0 | 13 | 0 |
| other | Retinoschisis | Eye disorders | High Dose Somatropin | 0 | 14 | 0 |
| other | Retinoschisis | Eye disorders | Label Dose Somatropin | 1 | 13 | 1 |
| other | Chest pain | General disorders | High Dose Somatropin | 1 | 14 | 1 |
| other | Chest pain | General disorders | Label Dose Somatropin | 0 | 13 | 0 |
| other | Pyrexia | General disorders | High Dose Somatropin | 2 | 14 | 2 |
| other | Pyrexia | General disorders | Label Dose Somatropin | 2 | 13 | 2 |
| other | Ear infection | Infections and infestations | High Dose Somatropin | 1 | 14 | 2 |
| other | Ear infection | Infections and infestations | Label Dose Somatropin | 0 | 13 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose Somatropin | ||
| Total, all-cause mortality | Label Dose Somatropin | ||
| Total, other adverse events | High Dose Somatropin | 13 | |
| Total, other adverse events | Label Dose Somatropin | 5 | |
| Total, serious adverse events | High Dose Somatropin | 1 | |
| Total, serious adverse events | Label Dose Somatropin | 0 |
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/NCT00191165
GET https://conductscience.org/api/trials/v1/NCT00191165/events?page=2