IGF-1 DeficiencyEDISONNCT01676090
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population
An observational study of IGF-1 Deficiency, run by Ipsen at 9 sites in Spain.
Trial summary
To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- IGF-1 Deficiency
- How many people
- 304 participants
- Where
- 9 sitesSpain
- Study dates
- Jul 2012to Oct 2013
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy paediatric Spanish population
Who may be able to join
- Children of either sex of Caucasian parents
- Age: newborns up to and including 18 years of age
- Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010)
- Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years
Who cannot join
- Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys)
- Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes
- An acute disease during the last two weeks prior to recruitment
- Any clinically significant out-of-range lab value
- Healthy paediatric volunteers who are under medical treatment (contraception permitted)
- A family history of short stature (either parent < P3)
Show all 9Show fewer
- Children born small for gestational age (birth weight, length, or head circumference < P10)
- Adopted children or conceived through in vitro fertilization ( IVF )
- Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Fundación Sant Joan de Deu
Barcelona
Hospital Universitari Vall d´Hebron
Barcelona
Hospital de Cruces
Bilbao
Hospital 12 de Octubre
Madrid
Hospital Infantil Universitario Niño Jesús
Madrid
Hospital Universitario La Paz
Madrid
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Universitario Nuestra Señora de Valme
Seville
Hospital Miguel Servet
Zaragoza
About this study
Official title: An Epidemiologic, Descriptive and Cross-sectional Study of the IGF-1, IGFBP-3 and ALS Normative Ranges in a Healthy Paediatric Spanish Population, Divided Into Chronological Age, Sex and Pubertal Stage
To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.
- Conditions
- IGF-1 Deficiency
- Medical subject headings
- Insulin-Like Growth Factor I Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
Measured: At the time of participant's single study visit (day 1)
Secondary outcomes (2)
IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers
Measured: At the time of participant's single study visit (day 1)
ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers
Measured: At the time of participant's single study visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Participant enrolment was lower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGF-1 DeficiencyStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676090
- Sponsor's protocol ID
- A-92-52800-020
- Acronym
- EDISON
- Status last verified
- Jan 2019
- First submitted
- 22 Aug 2012
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiologic, Descriptive and Cross-sectional Study of the IGF-1, IGFBP-3 and ALS Normative Ranges in a Healthy Paediatric Spanish Population, Divided Into Chronological Age, Sex and Pubertal Stage
- ClinicalTrials.gov ID
- NCT01676090
- Acronym / sponsor ID
- EDISON / A-92-52800-020
- Conditions
- IGF-1 Deficiency
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Participant enrolment was lower than expected
- Enrolment
- 304 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Aug 2012 (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 determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy paediatric Spanish population
Key inclusion criteria (4 listed)
- Children of either sex of Caucasian parents
- Age: newborns up to and including 18 years of age
- Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010)
- Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years
Key exclusion criteria (9 listed)
- Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys)
- Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes
- An acute disease during the last two weeks prior to recruitment
- Any clinically significant out-of-range lab value
- Healthy paediatric volunteers who are under medical treatment (contraception permitted)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
Time frame: At the time of participant's single study visit (day 1)
2 secondary outcomes
IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers
Time frame: At the time of participant's single study visit (day 1)
ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers
Time frame: At the time of participant's single study visit (day 1)
Results and safety
The study was stopped early (reason given: Participant enrolment was lower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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IGF1 Deficiency
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.
Ipsen Medical Director study director
Ipsen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IGF-1 Deficiency, run by Ipsen at 9 sites in Spain.
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 9 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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: Participant enrolment was lower than expected). 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?
IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers (time frame: At the time of participant's single study visit (day 1)). 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 11 Jan 2019.