Growth Hormone DisorderIMPACTNCT01068639
An Observational Study on Treatment Compliance by Children Treated With Growth Hormone
An observational study of Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S.
Trial summary
This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children
- What is being tested?
- No treatment given
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Apr 2010
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children treated for at least one year with growth hormone with any growth hormone product whatever the reason for prescription
Who may be able to join
- Child treated for at least one year with growth hormone any growth hormone product
- Followed by the participating paediatrician for at least 1 year.
Who cannot join
- Refusal to participate
- Child and/or parent unable to give consent or fill out the questionnaires
- Child participating in a therapeutic trial
About this study
Official title: IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France
This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.
- Being tested
- No treatment given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenBehavioural
No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Behavioral: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of injections omitted during the previous month
Measured: measured over the past 2 months (retrospective data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 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
- NCT01068639
- Sponsor's protocol ID
- GH-3787
- Other IDs
- U1111-1113-2490
- Acronym
- IMPACT
- Status last verified
- Jun 2014
- First submitted
- 12 Feb 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France
- ClinicalTrials.gov ID
- NCT01068639
- Acronym / sponsor ID
- IMPACT / GH-3787
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 15 Feb 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 Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: No treatment given |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children treated for at least one year with growth hormone with any growth hormone product whatever the reason for prescription
Key inclusion criteria (2 listed)
- Child treated for at least one year with growth hormone any growth hormone product
- Followed by the participating paediatrician for at least 1 year.
Key exclusion criteria (3 listed)
- Refusal to participate
- Child and/or parent unable to give consent or fill out the questionnaires
- Child participating in a therapeutic 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 |
|---|---|---|
| No treatment givenNo treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed. | Behavioural | A |
Primary outcome
Average number of injections omitted during the previous month
Time frame: measured over the past 2 months (retrospective data collection)
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 26 Jun 2014.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S.
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: withdrawn, as of the sponsor's last update on 26 Jun 2014. 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?
Average number of injections omitted during the previous month (time frame: measured over the past 2 months (retrospective data collection)). 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 26 Jun 2014.