Foetal Growth ProblemPhase 3NCT00557336
Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age
A Phase 3 study testing somatropin in people with Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 37 sites in Spain.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Foetal Growth Problem, Small for Gestational Age
- What is being tested?
- somatropin
- How many people
- 160 participants
- Where
- 37 sitesSpain
- Study dates
- 28 Jul 2003to 29 Jun 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
- Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
- Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
- Normal response to GH stimulation test (greater than 10 ng/mL)
Who cannot join
- Diabetes
- Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
- Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
- History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
- Previous or ongoing growth hormone therapy
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Spain37 sites
Novo Nordisk Investigational Site
Albacete, 02006
Novo Nordisk Investigational Site
Alicante, 03010
Novo Nordisk Investigational Site
Almería, 04009
Novo Nordisk Investigational Site
Badajoz, 06080
Novo Nordisk Investigational Site
Badalona, 08916
Novo Nordisk Investigational Site
Barcelona, 08009
Novo Nordisk Investigational Site
Barcelona, 08025
Novo Nordisk Investigational Site
Cáceres, 10002
Novo Nordisk Investigational Site
Calella de La Costa, 08370
Novo Nordisk Investigational Site
Córdoba, 14004
Novo Nordisk Investigational Site
El Palmar, 30120
Novo Nordisk Investigational Site
Elche, 3203
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950
Novo Nordisk Investigational Site
Getafe, 28905
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Granollers, 08400
Novo Nordisk Investigational Site
Huelva, 21005
Novo Nordisk Investigational Site
Jaén, 23007
Novo Nordisk Investigational Site
Las Palmas, 35016
Novo Nordisk Investigational Site
Leganés, 28911
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Madrid, 28009
Novo Nordisk Investigational Site
Madrid, 28041
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Málaga, 29011
Novo Nordisk Investigational Site
Martorell, 08760
Novo Nordisk Investigational Site
Mataró, 08304
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
Pamplona, 31008
Novo Nordisk Investigational Site
Sabadell, 08208
Novo Nordisk Investigational Site
Salamanca, 37007
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, 38010
Novo Nordisk Investigational Site
Santander, 39008
Novo Nordisk Investigational Site
Seville, 41014
Novo Nordisk Investigational Site
Tarrasa, 08227
Novo Nordisk Investigational Site
Vitoria-Gasteiz, 01009
Novo Nordisk Investigational Site
Zaragoza, 50009
About this study
Official title: Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Being tested
- somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Height gain according to birth group, age of onset, the treatment and Tanner stage
Measured: during 12 months of treatment
Secondary outcomes (3)
Height SDS for bone age
Measured: during 12 months of treatment
Height velocity SDS for bone age
Measured: during 12 months of treatment
Height velocity for chronological age
Measured: during 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study start28 Jul 2003
- Primary completion29 Jun 2005
- Study completion29 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foetal Growth ProblemStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557336
- Sponsor's protocol ID
- GHLIQUID-1523
- Status last verified
- Feb 2017
- First submitted
- 12 Nov 2007
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR
- ClinicalTrials.gov ID
- NCT00557336
- Acronym / sponsor ID
- GHLIQUID-1523
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2003 (actual)
- Primary completion
- 29 Jun 2005 (actual)
- Study completion
- 29 Jun 2005 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
- Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
- Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
- Normal response to GH stimulation test (greater than 10 ng/mL)
Key exclusion criteria (5 listed)
- Diabetes
- Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
- Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
- History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
- Previous or ongoing growth hormone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropin | Drug | – |
Primary outcome
Height gain according to birth group, age of onset, the treatment and Tanner stage
Time frame: during 12 months of treatment
3 secondary outcomes
Height SDS for bone age
Time frame: during 12 months of treatment
Height velocity SDS for bone age
Time frame: during 12 months of treatment
Height velocity for chronological age
Time frame: during 12 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing somatropin in people with Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 37 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height gain according to birth group, age of onset, the treatment and Tanner stage (time frame: during 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.