Trial · NCT00249821
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
NCT00249821, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2012-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age. Trials, record NCT00249821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00249821
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
- NCT number
- NCT00249821
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Small Gestational Age (SGA)
- Interventions
- Saizen®, Saizen®
- First posted
- 2005-11-07
- Last updated
- 2017-09-26
- Results first posted
- 2012-10-10
- Limitations and caveats
- Participants' inclusion period was extended but due to remaining low recruitment rate, it was finally decided to stop enrollment even if only 22 participants were enrolled.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height Velocity | Month 12 | Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely: HV = {(h-hp)/(d-dp)} \* 365.25 \[centimeter (cm)/year\] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years. HV is the mean height velocity over the interval between d and dp but is displayed as HV at d. |
| Secondary | Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Baseline (randomization), Month 6 and Month 12 | Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) \[age and sex-matched reference\]. Greater H-SDS indicates greater height. |
| Secondary | Height Velocity-Standard Deviation Score (HV-SDS) | Month 6 and Month 12 | Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity. |
| Secondary | Change From Baseline in Height at Month 6 | Baseline (randomization) and Month 6 | |
| Secondary | Change From Baseline in Bone Age at Month 12 | Baseline (randomization) and Month 12 | Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method. |
| Secondary | Insulin Like Growth Factor-1 (IGF-1) Levels | Baseline (randomization), Month 6 and Month 12 | |
| Secondary | Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels | Baseline (randomization), Month 6 and Month 12 | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline (randomization) until Month 12 | Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Height Velocity | Month 12 | Full Analysis (FA) set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Last observation carried forward (LOCF) was used to impute missing values. | centimeter (cm)/year | MEAN |
| SECONDARY | Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Baseline (randomization), Month 6 and Month 12 | FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values. | standard deviation score | MEAN |
| SECONDARY | Height Velocity-Standard Deviation Score (HV-SDS) | Month 6 and Month 12 | FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Here n signifies number of participants analyzed at that particular time point for each arm group respectively. LOCF was used to impute missing values. | standard deviation score | MEAN |
| SECONDARY | Change From Baseline in Height at Month 6 | Baseline (randomization) and Month 6 | FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values. | cm | MEAN |
| SECONDARY | Change From Baseline in Bone Age at Month 12 | Baseline (randomization) and Month 12 | FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively. | years | MEAN |
| SECONDARY | Insulin Like Growth Factor-1 (IGF-1) Levels | Baseline (randomization), Month 6 and Month 12 | FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively. | microgram/liter (mcg/L) | MEAN |
| SECONDARY | Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels | Baseline (randomization), Month 6 and Month 12 | FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively. | milligram/L (mg/L) | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline (randomization) until Month 12 | The safety population included all the participants who received at least 1 dose of study medication. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Height Velocity | Saizen® 0.057 mg/kg/Day | 6.40 | Standard Deviation 1.35 | centimeter (cm)/year | |
| Height Velocity | Saizen® 0.035 mg/kg/Day | 4.40 | Standard Deviation 1.15 | centimeter (cm)/year | |
| Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Saizen® 0.057 mg/kg/Day | Baseline (randomization) | -1.30 | Standard Deviation 0.42 | standard deviation score |
| Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Saizen® 0.035 mg/kg/Day | Baseline (randomization) | -1.50 | Standard Deviation 0.37 | standard deviation score |
| Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Saizen® 0.057 mg/kg/Day | Change at Month 6 | 0.30 | Standard Deviation 0.22 | standard deviation score |
| Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Saizen® 0.035 mg/kg/Day | Change at Month 6 | 0.10 | Standard Deviation 0.10 | standard deviation score |
| Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Saizen® 0.057 mg/kg/Day | Change at Month 12 | 0.30 | Standard Deviation 0.30 | standard deviation score |
| Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 | Saizen® 0.035 mg/kg/Day | Change at Month 12 | -0.10 | Standard Deviation 0.24 | standard deviation score |
| Height Velocity-Standard Deviation Score (HV-SDS) | Saizen® 0.057 mg/kg/Day | Month 6 (n= 10,11) | 0.60 | Standard Deviation 0.44 | standard deviation score |
| Height Velocity-Standard Deviation Score (HV-SDS) | Saizen® 0.035 mg/kg/Day | Month 6 (n= 10,11) | 0.10 | Standard Deviation 0.22 | standard deviation score |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saizen® 0.057 mg/kg/Day | 10 | |
| Overall Study | STARTED | Saizen® 0.035 mg/kg/Day | 12 | |
| Overall Study | COMPLETED | Saizen® 0.057 mg/kg/Day | 10 | |
| Overall Study | COMPLETED | Saizen® 0.035 mg/kg/Day | 11 | |
| Overall Study | NOT COMPLETED | Saizen® 0.057 mg/kg/Day | 0 | |
| Overall Study | NOT COMPLETED | Saizen® 0.035 mg/kg/Day | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | Asthma | Immune system disorders | Saizen® 0.057 mg/kg/Day | 0 | 10 | 0 |
| other | Asthma | Immune system disorders | Saizen® 0.035 mg/kg/Day | 1 | 12 | 1 |
| other | Bronchitis | Infections and infestations | Saizen® 0.057 mg/kg/Day | 1 | 10 | 1 |
| other | Bronchitis | Infections and infestations | Saizen® 0.035 mg/kg/Day | 0 | 12 | 0 |
| other | Ear infection | Infections and infestations | Saizen® 0.057 mg/kg/Day | 1 | 10 | 2 |
| other | Ear infection | Infections and infestations | Saizen® 0.035 mg/kg/Day | 0 | 12 | 0 |
| other | Insulin-like growth factor increased | Investigations | Saizen® 0.057 mg/kg/Day | 1 | 10 | 1 |
| other | Insulin-like growth factor increased | Investigations | Saizen® 0.035 mg/kg/Day | 0 | 12 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saizen® 0.057 mg/kg/Day | ||
| Total, all-cause mortality | Saizen® 0.035 mg/kg/Day | ||
| Total, other adverse events | Saizen® 0.057 mg/kg/Day | 2 | 10 |
| Total, other adverse events | Saizen® 0.035 mg/kg/Day | 1 | 12 |
| Total, serious adverse events | Saizen® 0.057 mg/kg/Day | 0 | 10 |
| Total, serious adverse events | Saizen® 0.035 mg/kg/Day | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22508151 | RESULT |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Saizen® 0.057 mg/kg/Day vs Saizen® 0.035 mg/kg/Day: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Saizen® 0.057 mg/kg/Day vs Saizen® 0.035 mg/kg/Day: serious adverse events | 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/NCT00249821
GET https://conductscience.org/api/trials/v1/NCT00249821/results?page=2