Growth DisordersPhase 3NCT01073605
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
A Phase 3 study testing Genotonorm in people with Growth Disorders and Intrauterine Growth Retardation, run by Pfizer at 31 sites in France.
Trial summary
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Growth Disorders, Intrauterine Growth Retardation
- What is being tested?
- Genotonorm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 31 sitesFrance
- Study dates
- Jul 1993to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronological age (CA) between 3 and 10 for girls
- Chronological age between 3 and 12 for boys
- Height for CA below - 2 SD
- Birth length for CA below -2SD
Who cannot join
- Endocrine disease except well-substituted hypothyroidism
- Sever chronic disease
- Skeletal dysplasia
- Known chromosomal aberration
- Ongoing treatment with steroids
- Known intrauterine infection
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Pfizer Investigational Site
Amiens, 80030
Pfizer Investigational Site
Angers, France, 49933
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Boulogne, 92100
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Bron, 69677
Pfizer Investigational Site
Clermont-Ferrand, 63000
Pfizer Investigational Site
Dijon, 21034
Pfizer Investigational Site
Grenoble, France, 38043
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Hyères, 83407
Pfizer Investigational Site
Lille, 59000
Pfizer Investigational Site
Lille, 59037
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Montpellier, 34059
Pfizer Investigational Site
Nantes, 44093
Pfizer Investigational Site
Nice, 06202
Pfizer Investigational Site
Paris, France, 75674
Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Paris, 75571
Pfizer Investigational Site
Reims, 51092
Pfizer Investigational Site
Rennes, 35033
Pfizer Investigational Site
Rouen, 76000
Pfizer Investigational Site
Saint-Priest-en-Jarez, 42277
Pfizer Investigational Site
Strasbourg, 67098
Pfizer Investigational Site
Tarbes
Pfizer Investigational Site
Toulouse, 31026
Pfizer Investigational Site
Tours, 37044
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
- Conditions
- Growth Disorders, Intrauterine Growth Retardation
- Being tested
- Genotonorm
- Keywords
- Short height, intra-uterine growth retardation, Genotonorm, continuous treatment, intermittent treatment
- Medical subject headings
- Growth Disorders, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotonormDrug
0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
GenotonormDrug
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
GenotonormDrug
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
| Study group | Role | What they receive |
|---|---|---|
| Genotonorm A | Active comparator | Continuous 0.7 IU/kg/week or 0.03 mg/kg/day Receives: Drug: Genotonorm |
| Genotonorm B | Active comparator | Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day Receives: Drug: Genotonorm |
| Genotonorm C | Active comparator | Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day Receives: Drug: Genotonorm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
Measured: Baseline, 2 years
Secondary outcomes (12)
Annual Growth Rate Standard Deviation Score (SDS)
Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.
Measured: Baseline, 1 to 6 years
Change From Baseline in Annual Growth Rate SDS
Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.
Measured: Baseline, 1 to 3 years
Height (cm)
Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Measured: Baseline, 1 to 6 years, final height
Change From Baseline in Height (cm)
Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Measured: Baseline, 1 to 6 years, final height
Height (SDS)
Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Measured: Baseline, 1 to 6 years, final height
Change From Baseline in Height (SDS)
Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Measured: Baseline, 1 to 6 years, final height
Body Mass Index (BMI)
BMI was calculated by weight divided by height squared.
Measured: Baseline, 1 to 6 years
Weight
Measured: Baseline, 1 to 6 years
Change From Baseline in Bone Age
Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year
Measured: Baseline, 1 to 3 years
Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio
Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.
Measured: 1 to 3 years
Chronological Age at Onset of Puberty
Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.
Measured: Onset of puberty
Number of Subjects Reaching Puberty
The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.
Measured: Baseline, 1 to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJul 1993
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
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
- NCT01073605
- Sponsor's protocol ID
- 93-8122-001
- Other IDs
- A6281186, CTN 93-8122-001
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 18 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
- ClinicalTrials.gov ID
- NCT01073605
- Acronym / sponsor ID
- 93-8122-001
- Conditions
- Growth Disorders, Intrauterine Growth Retardation
- Keywords
- Short height, intra-uterine growth retardation, Genotonorm, continuous treatment, intermittent treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 1993
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 31 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotonorm A | Active comparator | Drug: GenotonormContinuous 0.7 IU/kg/week or 0.03 mg/kg/day |
| Genotonorm B | Active comparator | Drug: GenotonormContinuous, 1.4 IU/kg/week or 0.06 mg/kg/day |
| Genotonorm C | Active comparator | Drug: GenotonormIntermittent, 1.4 IU/kg/week or 0.06 mg/kg/day |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Chronological age (CA) between 3 and 10 for girls
- Chronological age between 3 and 12 for boys
- Height for CA below - 2 SD
- Birth length for CA below -2SD
Key exclusion criteria (6 listed)
- Endocrine disease except well-substituted hypothyroidism
- Sever chronic disease
- Skeletal dysplasia
- Known chromosomal aberration
- Ongoing treatment with steroids
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 |
|---|---|---|
| Genotonorm0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection | Drug | Genotonorm A |
| Genotonorm1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection | Drug | Genotonorm B |
| Genotonorm1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without) | Drug | Genotonorm C |
Primary outcome
Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
Time frame: Baseline, 2 years
Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
12 secondary outcomes
Annual Growth Rate Standard Deviation Score (SDS)
Time frame: Baseline, 1 to 6 years
Change From Baseline in Annual Growth Rate SDS
Time frame: Baseline, 1 to 3 years
Height (cm)
Time frame: Baseline, 1 to 6 years, final height
Change From Baseline in Height (cm)
Time frame: Baseline, 1 to 6 years, final height
Height (SDS)
Time frame: Baseline, 1 to 6 years, final height
Change From Baseline in Height (SDS)
Time frame: Baseline, 1 to 6 years, final height
Body Mass Index (BMI)
Time frame: Baseline, 1 to 6 years
Weight
Time frame: Baseline, 1 to 6 years
Change From Baseline in Bone Age
Time frame: Baseline, 1 to 3 years
Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio
Time frame: 1 to 3 years
Chronological Age at Onset of Puberty
Time frame: Onset of puberty
Number of Subjects Reaching Puberty
Time frame: Baseline, 1 to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genotonorm in people with Growth Disorders and Intrauterine Growth Retardation, run by Pfizer at 31 sites 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 4 inclusion and 6 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 18 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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?
Yes. Results are posted in the registry (first posted 31 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm (time frame: Baseline, 2 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 18 Nov 2010.