AcromegalyNCT01333384
Study in Polish Acromegalic Patients Treated With Somatuline Autogel
An observational study of Acromegaly, run by Ipsen at 1 site in Poland.
Trial summary
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2010to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Observation of 150 patients out of 500 routinely treated with somatostatin analogues in Poland
Who may be able to join
- Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
- Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available
Who cannot join
- Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
Measured: 24 months
Secondary outcomes (2)
Mean growth hormone (GH) levels
Measured: 24 months
Proportion of patients with GH levels below 1.0 microgram/liter
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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
- Other
- Enrolment
- 150 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
- NCT01333384
- Sponsor's protocol ID
- A-38-52030-739
- Status last verified
- Jan 2019
- First submitted
- 8 Apr 2011
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
- ClinicalTrials.gov ID
- NCT01333384
- Acronym / sponsor ID
- A-38-52030-739
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Apr 2011 (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.
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Observation of 150 patients out of 500 routinely treated with somatostatin analogues in Poland
Key inclusion criteria (2 listed)
- Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
- Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available
Key exclusion criteria (1 listed)
- Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
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
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
Time frame: 24 months
2 secondary outcomes
Mean growth hormone (GH) levels
Time frame: 24 months
Proportion of patients with GH levels below 1.0 microgram/liter
Time frame: 24 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 7 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 Acromegaly, run by Ipsen at 1 site in Poland.
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 2 inclusion and 1 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 7 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 Poland. 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?
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels (time frame: 24 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 7 Jan 2019.