Growth Hormone DeficiencyPhase 3NCT00884000
A Study of Zomacton in Children With Growth Hormone Deficiency
A Phase 3 study testing Genotropin and Zomacton in people with Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 43 sites in 7 countries.
Trial summary
This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Genotropin and Zomacton
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 43 sitesin 7 countries
- Study dates
- Jan 2010to Jul 2012
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent
- Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
- Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of <10ng/ml pr lower if so required by the country specific board(s)
- Height SDS <-2 SD of ref value for CA
- Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
- Height recorded for at least 6 months but not more than 18 months of pre-screening
- The difference between CA-BA≥ 1
- A positive locally performed GH stimulation test (defined as a peak plasma level of<9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening
Who cannot join
- BA above 9 yrs for girls and 10 yrs for boys
- Puberty Tanner stage >1
- Weight <12 Kg at screening
- Any prior treatment with GH
- Closed epiphysis
- Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
Show all 15Show fewer
- Any other diagnosed or suspected endocrine or metabolic disorder
- Any diagnosed or suspected sever chronic disease
- Clinical signs of dysmorphic features, malformations or mental retardations
- Growth failure due to other disorders
- Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
- Diagnosed malignant disease
- Any abnormal CS lab results that requires further investigation
- Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial
- Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
Trial locations and contacts
43 sites in 7 countries.
43 sites in 7 countries
India8 sites
Associates in Clinical Endocrinology Education and Research (ACEER)
Chennai
Apollo Hospitals
Hyderabad
TOTALL Diabetes Hormone Institute
Indore
KEM Hospital
Mumbai
Prince Aly Khan Hospital
Mumbai
Endocare Clinic
Nashik
Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
Pune
Health & Research Centre
Trivandrum
Israel7 sites
Haemek Medical Center
Afula
Soroka University Medical Center
Beersheba
Western Galilee Medical Center
Nahariya
Schneider Children's Medical Center of Israel
Petah Tikva
Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
Dana Children's Hospital - Tel-Aviv Sourasky Medical Center
Tel Aviv
Ukraine7 sites
Donetsk Regional Clinical Children's Hospital
Donetsk
Ivano-Frankivsk Regional Children Clinical Hospital
Ivano-Frankivsk
Kharkiv Regional Clinical Children's Hospital
Kharkiv
Institute of Endocrinology and Metabolism
Kiev
Ukrainian Children's Specialized Clinical Hospital
Kiev
Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)
Odesa
Zaporizhzhya Regional Paediatric Hospital
Zaporizhya
Romania6 sites
Societatea Civila Medicala "Dr. Paveliu"
Bucharest
Spitalul Clinic Municipal "Filantropia"
Craiova
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"
Iași
Spitalul Clinic Judetean Mures
Târgu Mureş
Paediatric Endocrinology/Medicali's SRL
Timișoara
Spitalul Clinic pentru Copii Louis Turcanu
Timișoara
Russia6 sites
State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV
Kazan'
Federal State Institution
Moscow
Russian Medical Academy of Post-graduate Education
Moscow
Saint-Petersburg State Health Care Institution
Saint Petersburg
State Educational Institution for Higher Professional Education
Saratov
State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV
Tomsk
Hungary5 sites
Semmelweiss University, 1st dept of paediatrics
Budapest
Szent Janos Kh Budai
Budapest
Petz Country Teaching Hospital
Győr
University of Szeged
Szeged
Markusovszkty Teaching Hospital
Szombathely
Poland4 sites
Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy
Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Gdańsk
Gdansk
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow
SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin
Szczecin
About this study
Official title: A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency
This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Genotropin, Zomacton
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotropinDrug
ZomactonDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Genotropin |
| 2 | Experimental | Not described Receives: Drug: Zomacton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height Velocity
Measured: 12 months
Secondary outcomes (7)
Height SDS
Measured: 12 months
Height velocity SDS
Measured: 12 months
Change in IGF-1 and IGFBP-3
Measured: 12 months
BA (Bone Age)
Measured: 12 months
Anti-hGH AB
Measured: 12 months
AE and tolerability
Measured: 12 months
CS Changes in safety lab, physical examination and vital signs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJul 2012
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 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
- NCT00884000
- Sponsor's protocol ID
- FE999905 CS07
- Other IDs
- 2008-004849-28, 2008
- Status last verified
- Jul 2012
- First submitted
- 17 Apr 2009
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT00884000
- Acronym / sponsor ID
- FE999905 CS07
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Apr 2009 (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 trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Genotropin |
| 2 | Experimental | Drug: Zomacton |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Signed informed consent
- Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
- Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of <10ng/ml pr lower if so required by the country specific board(s)
- Height SDS <-2 SD of ref value for CA
- Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
Key exclusion criteria (15 listed)
- BA above 9 yrs for girls and 10 yrs for boys
- Puberty Tanner stage >1
- Weight <12 Kg at screening
- Any prior treatment with GH
- Closed epiphysis
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 |
|---|---|---|
| Genotropin | Drug | 1 |
| Zomacton | Drug | 2 |
Primary outcome
Height Velocity
Time frame: 12 months
7 secondary outcomes
Height SDS
Time frame: 12 months
Height velocity SDS
Time frame: 12 months
Change in IGF-1 and IGFBP-3
Time frame: 12 months
BA (Bone Age)
Time frame: 12 months
Anti-hGH AB
Time frame: 12 months
AE and tolerability
Time frame: 12 months
CS Changes in safety lab, physical examination and vital signs
Time frame: 12 months
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 17 Jul 2012.
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
43 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genotropin and Zomacton in people with Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 43 sites in 7 countries.
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 8 inclusion and 15 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 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in India, Israel, Ukraine, Romania, Russia and 2 more countries. 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?
Height Velocity (time frame: 12 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 17 Jul 2012.