Foetal Growth ProblemPhase 3NCT00184756
Efficacy on Height in SGA Children Treated With Growth Hormone
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 8 countries.
Trial summary
This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Foetal Growth Problem, Small for Gestational Age
- What is being tested?
- somatropin
- How many people
- 151 participants
- Where
- 37 sitesin 8 countries
- Study dates
- Nov 2002to Jul 2006
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
- Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion
Who cannot join
- Growth Hormone Deficiency (GHD)
- Treatment with any medical product which may interfere with GH effects
- Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
Spain9 sites
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Esplugues Llobregat, 08950
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Madrid, 28009
Novo Nordisk Investigational Site
Madrid, 28046
Novo Nordisk Investigational Site
Málaga, 29011
Novo Nordisk Investigational Site
Santiago de Compostela, 15705
Novo Nordisk Investigational Site
Valencia, 46026
Czechia6 sites
Novo Nordisk Investigational Site
Brno, 61300
Novo Nordisk Investigational Site
Olomouc, 77520
Novo Nordisk Investigational Site
Prague, 10081
Novo Nordisk Investigational Site
Prague, 116 94
Novo Nordisk Investigational Site
Prague, 15006
Novo Nordisk Investigational Site
Usti N. Labem, 40011
Germany5 sites
Novo Nordisk Investigational Site
Gotha, 99867
Novo Nordisk Investigational Site
Heidelberg, 69120
Novo Nordisk Investigational Site
Krefeld, 47805
Novo Nordisk Investigational Site
Leipzig, 04317
Novo Nordisk Investigational Site
Wuppertal, 42283
Israel4 sites
Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Petah Tikva, 49202
Novo Nordisk Investigational Site
Rehovot, 76100
Portugal4 sites
Novo Nordisk Investigational Site
Coimbra, 3000-075
Novo Nordisk Investigational Site
Matosinhos Municipality, 4460
Novo Nordisk Investigational Site
Porto, 4200-319
Novo Nordisk Investigational Site
Vila Nova de Gaia, 4400-129
Finland3 sites
Novo Nordisk Investigational Site
Helsinki, 00029
Novo Nordisk Investigational Site
Kuopio, 70211
Novo Nordisk Investigational Site
Oulu, 90029
Poland3 sites
Novo Nordisk Investigational Site
Cracow, 30-663
Novo Nordisk Investigational Site
Gdansk, 80-952
Novo Nordisk Investigational Site
Warsaw, 04-736
Sweden3 sites
Novo Nordisk Investigational Site
Helsingborg, 251 87
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Stockholm, 171 76
About this study
Official title: Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.
This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.
- 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.
Evaluate effect on Height in SGA Children Treated with Growth Hormone
Measured: After 2 years of treatment
Secondary outcomes (2)
Appetite
Height SDS, yearly
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 startNov 2002
- Primary completionJul 2006
- Study completionJul 2006
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 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
- NCT00184756
- Sponsor's protocol ID
- GHLIQUID-1424
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Phillip M, Lebl J, Zuckerman-Levin N, Korpal-Szczyrska M, Sales Marques J, Ibáñez L on behalf of the European Norditropin SGA study group. Multinational study in short SGA children: evaluation of the effect of three different growth hormone dose regimens. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.
- ClinicalTrials.gov ID
- NCT00184756
- Acronym / sponsor ID
- GHLIQUID-1424
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (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 and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
- Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion
Key exclusion criteria (3 listed)
- Growth Hormone Deficiency (GHD)
- Treatment with any medical product which may interfere with GH effects
- Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders
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
Evaluate effect on Height in SGA Children Treated with Growth Hormone
Time frame: After 2 years of treatment
2 secondary outcomes
Appetite
Height SDS, yearly
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 13 Jan 2017.
- Results publicationPhillip M, Lebl J, Zuckerman-Levin N, Korpal-Szczyrska M, Sales Marques J, Ibáñez L on behalf of the European Norditropin SGA study group. Multinational study in short SGA children: evaluation of the effect of three different growth hormone dose regimens. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki
- 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 8 countries: 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 8 countries.
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 2 inclusion and 3 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 13 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 37 sites in Spain, Czechia, Germany, Israel, Portugal and 3 more countries. 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?
Evaluate effect on Height in SGA Children Treated with Growth Hormone (time frame: After 2 years of treatment). 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 NCT00184756, 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 13 Jan 2017.