Growth Hormone DisorderNCT01109017
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
An observational study of Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- somatropin
- How many people
- 387 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2009to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study
Who may be able to join
- Severe adult growth hormone deficiency
Who cannot join
- Known or suspected allergy to study product(s) or related products
- Previous participation in the study
- Diabetes Mellitus
- Presence of malignant tumor(s)
- Pregnant or likely to get pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
- 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
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.
| Study group | Role | What they receive |
|---|---|---|
| Norditropin® | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Measured: after 5 years
Secondary outcomes (4)
Number of impaired glucose tolerance events during the study period
Measured: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Number of other types of adverse events (AEs) during the study period
Measured: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
Measured: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects of insulin-like growth factor-1 (IGF-I) levels
Measured: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2014
- Study completionDec 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 387 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
- NCT01109017
- Sponsor's protocol ID
- GH-3811
- Other IDs
- U1111-1114-6250, JapicCTI-101122
- Status last verified
- Jan 2015
- First submitted
- 19 Apr 2010
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD
- ClinicalTrials.gov ID
- NCT01109017
- Acronym / sponsor ID
- GH-3811
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Apr 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 Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norditropin® | – | Drug: somatropin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study
Key inclusion criteria (1 listed)
- Severe adult growth hormone deficiency
Key exclusion criteria (5 listed)
- Known or suspected allergy to study product(s) or related products
- Previous participation in the study
- Diabetes Mellitus
- Presence of malignant tumor(s)
- Pregnant or likely to get pregnant
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 |
|---|---|---|
| somatropinNorditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5. | Drug | Norditropin® |
Primary outcome
Number and type of suspected serious adverse drug reactions (SADRs) during the study period
Time frame: after 5 years
4 secondary outcomes
Number of impaired glucose tolerance events during the study period
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Number of other types of adverse events (AEs) during the study period
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
Effects of insulin-like growth factor-1 (IGF-I) levels
Time frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years
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 8 Jan 2015.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Japan.
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 1 inclusion and 5 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 8 Jan 2015. 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 Japan. 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 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?
Number and type of suspected serious adverse drug reactions (SADRs) during the study period (time frame: after 5 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 8 Jan 2015.