Foetal Growth ProblemPhase 3NCT00184691
Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
A Phase 3 study testing somatropin in people with Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 13 sites in Spain.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Foetal Growth Problem, Small for Gestational Age
- What is being tested?
- somatropin
- How many people
- 78 participants
- Where
- 13 sitesSpain
- Study dates
- Apr 1999to 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IUGR defined as birth length and/or weight below the lower limit (< P10) of the Lubchenco curves for the gestational age.
- Chronological age = 2-5 years
- HV below average for CA
- Insufficient catch-up growth (Height < P3 for chronological age, according to Hernández)
- Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
- Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
- Bone age (measured through Greulich and Pyle method) less than or equal to CA
Who cannot join
- Children born from multiple pregnancy
- Children with post-ischemic encephalopathy
- Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
- Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
- Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
- Nutritional disorders (celiac disease) or osteodystrophies
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- Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
- Abnormal karyotype
- Neoplasms
- Previous or ongoing chemotherapy and/or irradiation
- Renal dysfunction, defined as serum creatinine > 1 mg/dL
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Novo Nordisk Investigational Site
Barakaldo, 48903
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Cadiz, 11009
Novo Nordisk Investigational Site
Córdoba, 14004
Novo Nordisk Investigational Site
El Palmar, 30120
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Madrid, 28009
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Málaga, 29011
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, 38010
Novo Nordisk Investigational Site
Santiago de Compostela, 15705
Novo Nordisk Investigational Site
Seville, 41013
About this study
Official title: Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.
- 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.
Effect on Efficacy: Height SDS for chronological age
Measured: after 48 months
Safety: Bone maturation and glucose metabolism
Secondary outcomes (1)
Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 1999
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT00184691
- Sponsor's protocol ID
- GHRETARD-1106
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Argente J, Gracia R, Ibanez L, Oliver A, Borrajo E, Vela A, Lopez-Siguero JP, Moreno ML, Rodriguez-Hierro F; Spanish SGA Working Group. Improvement in growth after two years of growth hormone therapy in very young children born small for gestational age and without spontaneous catch-up growth: results of a multicenter, controlled, randomized, open clinical trial. J Clin Endocrinol Metab. 2007 Aug;92(8):3095-101. doi: 10.1210/jc.2007-0078. Epub 2007 May 29.
PubMed 17536000
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR
- ClinicalTrials.gov ID
- NCT00184691
- Acronym / sponsor ID
- GHRETARD-1106
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 16 Sep 2005 (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 trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- IUGR defined as birth length and/or weight below the lower limit (< P10) of the Lubchenco curves for the gestational age.
- Chronological age = 2-5 years
- HV below average for CA
- Insufficient catch-up growth (Height < P3 for chronological age, according to Hernández)
- Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
Key exclusion criteria (11 listed)
- Children born from multiple pregnancy
- Children with post-ischemic encephalopathy
- Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
- Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
- Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
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
Effect on Efficacy: Height SDS for chronological age
Time frame: after 48 months
Safety: Bone maturation and glucose metabolism
1 secondary outcome
Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels
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 18 Jan 2017.
- Results publication: PubMed 17536000Argente J, Gracia R, Ibanez L, Oliver A, Borrajo E, Vela A, Lopez-Siguero JP, Moreno ML, Rodriguez-Hierro F; Spanish SGA Working Group. Improvement in growth after two years of growth hormone therapy in very young children born small for gestational age and without spontaneous catch-up growth: results of a multicenter, controlled, randomized, open clinical trial. J Clin Endocrinol Metab. 2007 Aug;92(8):3095-101. doi: 10.1210/jc.2007-0078. Epub 2007 May 29.
- 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
13 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 13 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 7 inclusion and 11 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Effect on Efficacy: Height SDS for chronological age (time frame: after 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184691, which also lists 1 linked publication.
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 18 Jan 2017.