Growth Hormone DeficiencyNCT01731028
Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®
An observational study of Growth Hormone Deficiency, run by Ferring Pharmaceuticals.
Trial summary
The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Somatropin
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with inadequate secretion of growth-hormone; growth retardation due to Turner's syndrome
Who may be able to join
- therapeutic need according to the approved specific products characteristics (SPC)
Who cannot join
- contraindication according to the SPC
About this study
Official title: Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice
The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Somatropin
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Somatropin powder and solvent for solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Somatropin | Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Zomacton® treatment measured by the increase in body height per annuum
Measured: 5 years
Secondary outcomes (2)
Efficacy of Zomacton® treatment measured by the increase in body weight per annuum
Measured: 5 years
Safety of Zomacton® and the application device measured by local adverse reactions to the application device
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Change of local requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731028
- Sponsor's protocol ID
- 000091
- Status last verified
- Jan 2013
- First submitted
- 16 Nov 2012
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01731028
- Acronym / sponsor ID
- 000091
- Conditions
- Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change of local requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Nov 2012 (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.
The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somatropin | – | Drug: SomatropinChildren with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with inadequate secretion of growth-hormone; growth retardation due to Turner's syndrome
Key inclusion criteria (1 listed)
- therapeutic need according to the approved specific products characteristics (SPC)
Key exclusion criteria (1 listed)
- contraindication according to the SPC
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 |
|---|---|---|
| SomatropinSomatropin powder and solvent for solution for injection | Drug | Somatropin |
Primary outcome
Efficacy of Zomacton® treatment measured by the increase in body height per annuum
Time frame: 5 years
2 secondary outcomes
Efficacy of Zomacton® treatment measured by the increase in body weight per annuum
Time frame: 5 years
Safety of Zomacton® and the application device measured by local adverse reactions to the application device
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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.
Clinical Development Support study director
Ferring Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Ferring Pharmaceuticals.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of Zomacton® treatment measured by the increase in body height per annuum (time frame: 5 years). 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 1 Feb 2013.