Growth Hormone DisordersNCT00455884
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
An observational study of Growth Hormone Disorders, run by Ipsen at 1 site in United Kingdom.
Trial summary
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Hormone Disorders
- How many people
- 546 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Dec 2011
- 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 treated with NutropinAq in the specialised adult endocrinology centres in Germany, Italy, and UK.
Who may be able to join
- Patients with Growth Hormone Deficiency
- Patients treated with NutropinAq®
- Patients having completed growth (fused epiphyses)
Who cannot join
- Active neoplasia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom
- Conditions
- Growth Hormone Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Measured: when reported
Secondary outcomes (3)
Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death
Measured: when reported
Incidence of intercurrent cardiovascular events
Measured: when reported
Incidence of fractures
Measured: when reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJun 2006
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 546 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
- NCT00455884
- Sponsor's protocol ID
- 2-79-58035-006
- Status last verified
- Jan 2019
- First submitted
- 3 Apr 2007
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Cooperative Metabolic Study (iNCMS) of NutropinAq® [Somatropin (rDNA Origin) Injection] Replacement Therapy in Adults With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT00455884
- Acronym / sponsor ID
- 2-79-58035-006
- Conditions
- Growth Hormone Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Apr 2007 (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 a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients treated with NutropinAq in the specialised adult endocrinology centres in Germany, Italy, and UK.
Key inclusion criteria (3 listed)
- Patients with Growth Hormone Deficiency
- Patients treated with NutropinAq®
- Patients having completed growth (fused epiphyses)
Key exclusion criteria (2 listed)
- Active neoplasia
- Pregnancy
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
Incidence of serious adverse events
Time frame: when reported
3 secondary outcomes
Incidence of targeted adverse events, including adrenal insufficiency, arthritis, carpal tunnel syndrome, intracranial hypertension, new onset and recurrence of leukemia & tumor, pancreatitis, peripheral edema requiring medical intervention and death
Time frame: when reported
Incidence of intercurrent cardiovascular events
Time frame: when reported
Incidence of fractures
Time frame: when reported
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 14 Jan 2019.
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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.
Ipsen Medical Director study director
Ipsen
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 Disorders, run by Ipsen at 1 site in United Kingdom.
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 3 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 14 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 1 site in United Kingdom. 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?
Incidence of serious adverse events (time frame: when reported). 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 14 Jan 2019.