Growth Hormone DisorderPhase 4NCT00567385
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
A Phase 4 study testing somatropin in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in Turkey (Türkiye).
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children
- What is being tested?
- somatropin
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2003to 22 Mar 2004
- Phase
- Phase 4
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Growth failure due to growth hormone insufficiency (GHD)
- Turner syndrome: established diagnosis according to sex chromosome analysis, or
- Growth retardation in children with chronic renal disorders
Who cannot join
- Pregnancy
- Breast feeding women
- Suspected or know allergy to trial product
- Participating in any other trial involving other investigational products within the last 3 months
- Previous participation in the trial
- Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Novo Nordisk Investigational Site
Altunizade-Istanbul, 34662
About this study
Official title: An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.
- 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.
Assessment of acceptance
Measured: after 12 weeks of treatment
Secondary outcomes (3)
Safety
Adverse Events (AE)
Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study start10 Mar 2003
- Primary completion22 Mar 2004
- Study completion22 Mar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 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
- NCT00567385
- Sponsor's protocol ID
- GHLIQUID-1515
- Status last verified
- Feb 2017
- First submitted
- 30 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
- An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
- ClinicalTrials.gov ID
- NCT00567385
- Acronym / sponsor ID
- GHLIQUID-1515
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2003 (actual)
- Primary completion
- 22 Mar 2004 (actual)
- Study completion
- 22 Mar 2004 (actual)
- First posted
- 4 Dec 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 trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Growth failure due to growth hormone insufficiency (GHD)
- Turner syndrome: established diagnosis according to sex chromosome analysis, or
- Growth retardation in children with chronic renal disorders
Key exclusion criteria (6 listed)
- Pregnancy
- Breast feeding women
- Suspected or know allergy to trial product
- Participating in any other trial involving other investigational products within the last 3 months
- Previous participation in the trial
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
Assessment of acceptance
Time frame: after 12 weeks of treatment
3 secondary outcomes
Safety
Adverse Events (AE)
Compliance
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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing somatropin in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 1 site in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Assessment of acceptance (time frame: after 12 weeks 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.