Growth Hormone DeficiencyPhase 3NCT00174278
Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
A Phase 3 study testing Somatropin in people with Growth Hormone Deficiency and Growth Retardation, run by Pfizer at 1 site in France.
Trial summary
To assess the effect of long-term treatment by Genotonorm on linear growth Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Growth Hormone Deficiency, Growth Retardation
- What is being tested?
- Somatropin
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Feb 1997to Oct 2006
- Phase
- Phase 3
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
- All patients who have stopped during one year will be included if a signed written informed consent
Who cannot join
- Endocrine disease, except well substituted hypothyroidism
- Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.
To assess the effect of long-term treatment by Genotonorm on linear growth
- Conditions
- Growth Hormone Deficiency, Growth Retardation
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 1997
- Study completionOct 2006
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 Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174278
- Sponsor's protocol ID
- 96-8123-018
- Other IDs
- A6281217
- Status last verified
- Aug 2008
- First submitted
- 9 Sep 2005
- Last updated
- 5 Aug 2008
- Results posted
- No
Publications
David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.
PubMed 29029101
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.
- ClinicalTrials.gov ID
- NCT00174278
- Acronym / sponsor ID
- 96-8123-018
- Conditions
- Growth Hormone Deficiency, Growth Retardation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 1997
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Sep 2005 (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.
To assess the effect of long-term treatment by Genotonorm on linear growth
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
- All patients who have stopped during one year will be included if a signed written informed consent
Key exclusion criteria (2 listed)
- Endocrine disease, except well substituted hypothyroidism
- Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
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
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
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 5 Aug 2008.
- Derived from this study: PubMed 29029101David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatropin in people with Growth Hormone Deficiency and Growth Retardation, run by Pfizer 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 2 inclusion and 2 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 5 Aug 2008. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The main efficacy variable is the height SDS (SEMPE) before and after treatment.. The study lists 7 primary outcomes in all. 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 NCT00174278, 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 5 Aug 2008.