Foetal Growth ProblemNCT01110928
Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
An observational study of Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foetal Growth Problem, Small for Gestational Age
- What is being tested?
- somatropin
- How many people
- 227 participants
- Where
- 1 siteJapan
- Study dates
- 26 Nov 2009to 12 Nov 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.
Who may be able to join
- Participation in the GHLIQUID-1517 trial
- Patients with SGA (small for gestational age) short stature that are still growing
Who cannot join
- Known or suspected allergy to study product(s) or related products
- Diabetes Mellitus
- Patients with malignant tumor(s)
- Pregnant or likely to get pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).
- 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
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.
| Study group | Role | What they receive |
|---|---|---|
| Norditropin® | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Measured: evaluated binannually for 9 years
Secondary outcomes (2)
Number of glucose intolerance events during the study period
Measured: evaluated biannually for 9 years
Adult height
Measured: Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study start26 Nov 2009
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 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
- NCT01110928
- Sponsor's protocol ID
- GH-3812
- Other IDs
- U1111-1114-6280, JapicCTI-101123
- Status last verified
- Jan 2019
- First submitted
- 19 Apr 2010
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Toshiaki Tanaka et al, The effect of growth hormone treatment on age and height at puberty onset in short Japanese children born small for gestational age: interim analysis of Norditropin post-marketing study; Japan, Journal of Japanese Association for Human Auxology; 2017: Vol 23 No. 2 : p59
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs
- ClinicalTrials.gov ID
- NCT01110928
- Acronym / sponsor ID
- GH-3812
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2009 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 27 Apr 2010 (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 study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norditropin® | – | Drug: somatropin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.
Key inclusion criteria (2 listed)
- Participation in the GHLIQUID-1517 trial
- Patients with SGA (small for gestational age) short stature that are still growing
Key exclusion criteria (4 listed)
- Known or suspected allergy to study product(s) or related products
- Diabetes Mellitus
- Patients with malignant tumor(s)
- Pregnant or likely to get pregnant
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 |
|---|---|---|
| somatropinNorditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit. | Drug | Norditropin® |
Primary outcome
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Time frame: evaluated binannually for 9 years
2 secondary outcomes
Number of glucose intolerance events during the study period
Time frame: evaluated biannually for 9 years
Adult height
Time frame: Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician
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 11 Jan 2019.
- BackgroundToshiaki Tanaka et al, The effect of growth hormone treatment on age and height at puberty onset in short Japanese children born small for gestational age: interim analysis of Norditropin post-marketing study; Japan, Journal of Japanese Association for Human Auxology; 2017: Vol 23 No. 2 : p59
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in Japan.
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 4 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 11 Jan 2019. 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 Japan. 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.
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?
Number and type of suspected serious adverse drug reactions (SADRs) during the study period (time frame: evaluated binannually for 9 years). 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 NCT01110928, 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 11 Jan 2019.