Trial · NCT00184717
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
NCT00184717, Phase 3, Completed, Novo Nordisk A/S; results first posted 2011-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Growth Hormone Treatment in Children Born Small for Gestational Age (SGA). Trials, record NCT00184717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00184717
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
- NCT number
- NCT00184717
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Interventions
- somatropin, somatropin
- First posted
- 2005-09-16
- Last updated
- 2017-07-07
- Other registries' IDs
- eudract:2017-000914-47
- Results first posted
- 2011-07-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0, week 260 | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit |
| Primary | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0, week 208 | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit |
| Secondary | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Weeks 0-260 | Yearly Height velocity SDS for chronological age were summarised and graphically presented |
| Secondary | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Weeks 0-208 | Yearly Height velocity SDS for chronological age were summarised and graphically presented |
| Secondary | Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0, week 260 | Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, …. |
| Secondary | Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0, week 208 | Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, …. |
| Secondary | Adverse Events - Subjects Received NN220 Treatment for 5 Years | Weeks 0-260 | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly |
| Secondary | Adverse Events - Subjects Received NN220 Treatment for 4 Years | Weeks 0-208 | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly |
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 | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0, week 260 | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Standard Deviation Score (SDS) | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0, week 208 | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Standard Deviation Score (SDS) | LEAST_SQUARES_MEAN |
| SECONDARY | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Weeks 0-260 | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Standard Deviation Score (SDS) | MEAN |
| SECONDARY | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Weeks 0-208 | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Standard Deviation Score (SDS) | MEAN |
| SECONDARY | Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0, week 260 | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | years | MEAN |
| SECONDARY | Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0, week 208 | Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | years | MEAN |
| SECONDARY | Adverse Events - Subjects Received NN220 Treatment for 5 Years | Weeks 0-260 | Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Subjects | NUMBER |
| SECONDARY | Adverse Events - Subjects Received NN220 Treatment for 4 Years | Weeks 0-208 | Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | 0.033 mg / NN-220 | Week 0 | -2.9488 | Standard Error 0.6368 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | 0.067 mg / NN-220 | Week 0 | -2.9047 | Standard Error 0.6718 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | 0.033 mg / NN-220 | Week 260 | 1.2066 | Standard Error 0.1102 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | 0.067 mg / NN-220 | Week 260 | 2.0247 | Standard Error 0.1083 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | No Treatment --> 0.033 mg | Week 0 | -2.9603 | Standard Error 0.6689 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | No Treatment --> 0.067 mg | Week 0 | -2.7481 | Standard Error 0.3524 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | No Treatment --> 0.033 mg | Week 208 | 1.0997 | Standard Error 0.2453 | Standard Deviation Score (SDS) |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | No Treatment --> 0.067 mg | Week 208 | 1.9151 | Standard Error 0.2275 | Standard Deviation Score (SDS) |
| Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | 0.033 mg / NN-220 | Baseline, n=31, 34 | -1.6299 | Standard Deviation 0.9738 | Standard Deviation Score (SDS) |
| Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | 0.067 mg / NN-220 | Baseline, n=31, 34 | -2.0303 | Standard Deviation 1.4527 | Standard Deviation Score (SDS) |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period (GHLIQUID-1516) | STARTED | 0.033 mg / NN-220 | 39 | |
| Main Period (GHLIQUID-1516) | STARTED | 0.067 mg / NN-220 | 38 | |
| Main Period (GHLIQUID-1516) | STARTED | No Treatment | 21 | |
| Main Period (GHLIQUID-1516) | STARTED | No Treatment --> 0.033 mg | 0 | |
| Main Period (GHLIQUID-1516) | STARTED | No Treatment --> 0.067 mg | 0 | |
| Main Period (GHLIQUID-1516) | Exposed to Trial Drug | 0.033 mg / NN-220 | 38 | |
| Main Period (GHLIQUID-1516) | Exposed to Trial Drug | 0.067 mg / NN-220 | 38 | |
| Main Period (GHLIQUID-1516) | Exposed to Trial Drug | No Treatment | 21 | |
| Main Period (GHLIQUID-1516) | Exposed to Trial Drug | No Treatment --> 0.033 mg | 0 | |
| Main Period (GHLIQUID-1516) | Exposed to Trial Drug | No Treatment --> 0.067 mg | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events584
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 | Abdominal pain | Gastrointestinal disorders | 0.033 mg / NN-220 | 4 | 31 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | 0.067 mg / NN-220 | 2 | 34 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | 0.033 mg / No Treatment | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | 0.067 mg / No Treatment | 0 | 8 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | 0.033 mg / NN-220 | 0 | 31 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | 0.067 mg / NN-220 | 3 | 34 | 4 |
| other | Acne | Skin and subcutaneous tissue disorders | 0.033 mg / No Treatment | 0 | 7 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | 0.067 mg / No Treatment | 0 | 8 | 0 |
| other | Acute sinusitis | Infections and infestations | 0.033 mg / NN-220 | 1 | 31 | 1 |
| other | Acute sinusitis | Infections and infestations | 0.067 mg / NN-220 | 2 | 34 | 8 |
1 to 10 of 584Source ClinicalTrials.gov
See all 584 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.033 mg / NN-220 | ||
| Total, all-cause mortality | 0.067 mg / NN-220 | ||
| Total, all-cause mortality | 0.033 mg / No Treatment | ||
| Total, all-cause mortality | 0.067 mg / No Treatment | ||
| Total, other adverse events | 0.033 mg / NN-220 | 31 | 31 |
| Total, other adverse events | 0.067 mg / NN-220 | 34 | 34 |
| Total, other adverse events | 0.033 mg / No Treatment | 7 | 7 |
| Total, other adverse events | 0.067 mg / No Treatment | 8 | 8 |
| Total, serious adverse events | 0.033 mg / NN-220 | 12 | 31 |
| Total, serious adverse events | 0.067 mg / NN-220 | 11 | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00184717
GET https://conductscience.org/api/trials/v1/NCT00184717/results?page=2