Growth Hormone DeficiencyZOMAXEPTNCT02018172
Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device
An observational study of Growth Hormone Deficiency and Turner's Syndrome, run by Ferring Pharmaceuticals at 1 site in France.
Trial summary
The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Hormone Deficiency, Turner's Syndrome
- What is being tested?
- somatropin
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Feb 2015
- 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 a growth hormone deficiency or Turner's syndrome.
Who may be able to join
- Patient with growth hormone deficiency,
- Diagnosis of growth hormone deficiency proven by appropriate exploration
- Size ≤ -2 Standard Deviation (SD) according to the French references
- Growth velocity in the previous year inferior to the normal for age (-1SD) or < 4cm/year
- Growth deficiency due to Turner's syndrome
- Turner's syndrome confirmed by a karyotype
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- Patient's size ≤ -2 SD according to the French references
- Bone age < 12 years
- Patient who require a minimum of 18 months of treatment.
Who cannot join
- There are no exclusion criteria except the contraindication for Zomacton® 10 mg
Trial locations and contacts
1 site in 1 country.
About this study
The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.
- Conditions
- Growth Hormone Deficiency, Turner's Syndrome
- Being tested
- somatropin
- Medical subject headings
- Dwarfism, Pituitary, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Also called Zomacton®
| Study group | Role | What they receive |
|---|---|---|
| Zomacton® treatment with Zomajet® Vision X device | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall treatment adherence
Ratio between actual duration of administration and total duration recommended by physician
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Terminated due to lack of recruitment and difficulty in the selection of sites
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
- 3 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
- NCT02018172
- Sponsor's protocol ID
- 000122
- Acronym
- ZOMAXEPT
- Status last verified
- May 2015
- First submitted
- 17 Dec 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device
- ClinicalTrials.gov ID
- NCT02018172
- Acronym / sponsor ID
- ZOMAXEPT / 000122
- Conditions
- Growth Hormone Deficiency, Turner's Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of recruitment and difficulty in the selection of sites
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Dec 2013 (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 study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zomacton® treatment with Zomajet® Vision X device | – | Drug: somatropin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a growth hormone deficiency or Turner's syndrome.
Key inclusion criteria (9 listed)
- Patient with growth hormone deficiency,
- Growth deficiency due to Turner's syndrome
- Patient who require a minimum of 18 months of treatment.
Key exclusion criteria (1 listed)
- There are no exclusion criteria except the contraindication for Zomacton® 10 mg
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 |
|---|---|---|
| somatropinAlso: Zomacton® | Drug | Zomacton® treatment with Zomajet® Vision X device |
Primary outcome
Rate of overall treatment adherence
Time frame: Up to 18 months
Ratio between actual duration of administration and total duration recommended by physician
Results and safety
The study was stopped early (reason given: Terminated due to lack of recruitment and difficulty in the selection of sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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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
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 Growth Hormone Deficiency and Turner's Syndrome, run by Ferring Pharmaceuticals at 1 site in France.
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 9 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: stopped early, as of the sponsor's last update on 12 May 2015. 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 France. 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 was stopped early (reason given: Terminated due to lack of recruitment and difficulty in the selection of sites). Results are not available in the source record.
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?
Rate of overall treatment adherence (time frame: Up to 18 months). 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 12 May 2015.