AcromegalyPhase 4NCT00149188
Somatuline Autogel: Acromegaly Self/Partner Injection Study
A Phase 4 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 10 sites in United Kingdom.
Trial summary
The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Lanreotide (Autogel formulation)
- How many people
- 30 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Feb 2004to 24 Aug 2005
- Phase
- Phase 4
- 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
Who may be able to join
- The patient must have a clinical diagnosis of acromegaly
- The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
- The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
- The patient must be able to store study medication in a refrigerator in their own home
Who cannot join
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
- The patient has received pituitary radiotherapy within one year prior to screening
- The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
- The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Dept of Endocrinology, Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Department of Medicine, Queen Elizabeth Hospital
Birmingham, B15 2TH
Department of Endocrinology, Coventry & Warwickshire Hospital
Coventry, CV1 4FH
Department of Endocrinology, The Royal Free Hospital
Hampstead, London, NW3 2QG
Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ
Department of Endocrinology, Leicester Royal Infirmary
Leicester, LE1 5WW
Department of Endocrinology, Manchester Royal Infirmary
Manchester, M13 9WL
The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
Oxford, OX3 7LJ
Department of Endocrinology, Royal Hallamshire Hospital
Sheffield, S10 2JF
Department of Endocrinology, Sunderland Royal Hospital
Sunderland, SR4 7TP
About this study
Official title: A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.
The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.
- Conditions
- Acromegaly
- Being tested
- Lanreotide (Autogel formulation)
- Keywords
- Growth Hormone
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide (Autogel formulation)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
Secondary outcomes (3)
To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
To assess patient/partner and healthcare professional experience with unsupervised injections.
To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completion24 Aug 2005
- Study completion24 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UK Medical Director, MD, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149188
- Sponsor's protocol ID
- Y-97-52030-150
- Status last verified
- Aug 2019
- First submitted
- 7 Sep 2005
- Last updated
- 5 Aug 2019
- Results posted
- No
Publications
Bevan JS, Newell-Price J, Wass JA, Atkin SL, Bouloux PM, Chapman J, Davis JR, Howlett TA, Randeva HS, Stewart PM, Viswanath A. Home administration of lanreotide Autogel by patients with acromegaly, or their partners, is safe and effective. Clin Endocrinol (Oxf). 2008 Mar;68(3):343-9. doi: 10.1111/j.1365-2265.2007.03044.x. Epub 2007 Sep 24.
PubMed 17892497
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.
- ClinicalTrials.gov ID
- NCT00149188
- Acronym / sponsor ID
- Y-97-52030-150
- Conditions
- Acromegaly
- Keywords
- Growth Hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- 24 Aug 2005 (actual)
- Study completion
- 24 Aug 2005 (actual)
- First posted
- 8 Sep 2005 (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 allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have a clinical diagnosis of acromegaly
- The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
- The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
- The patient must be able to store study medication in a refrigerator in their own home
Key exclusion criteria (4 listed)
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
- The patient has received pituitary radiotherapy within one year prior to screening
- The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
- The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel
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 |
|---|---|---|
| Lanreotide (Autogel formulation) | Drug | – |
Primary outcome
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
3 secondary outcomes
To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
To assess patient/partner and healthcare professional experience with unsupervised injections.
To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.
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 5 Aug 2019.
- Results publication: PubMed 17892497Bevan JS, Newell-Price J, Wass JA, Atkin SL, Bouloux PM, Chapman J, Davis JR, Howlett TA, Randeva HS, Stewart PM, Viswanath A. Home administration of lanreotide Autogel by patients with acromegaly, or their partners, is safe and effective. Clin Endocrinol (Oxf). 2008 Mar;68(3):343-9. doi: 10.1111/j.1365-2265.2007.03044.x. Epub 2007 Sep 24.
Related trials for Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
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.
UK Medical Director, MD study director
Ipsen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 10 sites 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 4 inclusion and 4 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149188, which also lists 1 linked publication.
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 5 Aug 2019.