AcromegalyPhase 3NCT00444873
Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
A Phase 3 study testing lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval in people with Acromegaly, run by Ipsen at 1 site in Germany.
Trial summary
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Jan 2008
- Phase
- Phase 3
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- The patient must have a documented diagnosis of active acromegaly and be adequately treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months immediately prior to study entry. A documented diagnosis of active acromegaly is defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral Glucose Tolerance Test) > 2ng/mL while not under drug treatment for acromegaly. For patients having undergone surgery or radiotherapy, this diagnosis must have been performed after the most recent surgical or radiation treatment
Who cannot join
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry
- The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly within three years or conventional radiotherapy for acromegaly within five years prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.
Read the detailed description
Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. The dose interval is titrated after injection 3 depending on the efficacy of the therapy with Lanreotide Autogel
- Conditions
- Acromegaly
- Being tested
- lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
- Keywords
- Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)
- 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), duration of treatment 24-56 weeks, depending on dose intervalDrug
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| 28 day dose interval | Experimental | Not described Receives: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
| 42 day dose interval | Experimental | Not described Receives: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
| 56 day dose interval | Experimental | Not described Receives: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels.
Measured: 1 dose interval after the last administration of Lanreotide Autogel 120mg
Secondary outcomes (3)
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg which are effective in reducing IGF-1 and GH levels to internationally accepted levels.
Measured: Last three injections of Lanreotiude Autogel 120mg
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg, which shows comparable efficacy to the previous treatment with Octreotide LAR 10, 20 or 30 mg in controlling IGF-1 and GH levels
Measured: Interval between doses after titration in part 2 of treatment (injections 3-6)
Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.
Measured: 1 dose interval after the last administration of Lanreotide Autogel 120mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT00444873
- Sponsor's protocol ID
- A-94-52030-163
- Other IDs
- 2004-001435-33, 2004
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2007
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plockinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel(R) 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR. Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):156-62. doi: 10.1055/s-0030-1267244. Epub 2010 Nov 17.
PubMed 21086246
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR
- ClinicalTrials.gov ID
- NCT00444873
- Acronym / sponsor ID
- A-94-52030-163
- Conditions
- Acromegaly
- Keywords
- Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Mar 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.
A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.
Detailed description
Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. The dose interval is titrated after injection 3 depending on the efficacy of the therapy with Lanreotide Autogel
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 28 day dose interval | Experimental | Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
| 42 day dose interval | Experimental | Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
| 56 day dose interval | Experimental | Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- The patient must have a documented diagnosis of active acromegaly and be adequately treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months immediately prior to study entry. A documented diagnosis of active acromegaly is defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral Glucose Tolerance Test) > 2ng/mL while not under drug treatment for acromegaly. For patients having undergone surgery or radiotherapy, this diagnosis must have been performed after the most recent surgical or radiation treatment
Key exclusion criteria (2 listed)
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry
- The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly within three years or conventional radiotherapy for acromegaly within five years prior to study entry
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), duration of treatment 24-56 weeks, depending on dose intervalSix deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals. | Drug | 28 day dose interval, 42 day dose interval, 56 day dose interval |
Primary outcome
Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels.
Time frame: 1 dose interval after the last administration of Lanreotide Autogel 120mg
3 secondary outcomes
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg which are effective in reducing IGF-1 and GH levels to internationally accepted levels.
Time frame: Last three injections of Lanreotiude Autogel 120mg
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg, which shows comparable efficacy to the previous treatment with Octreotide LAR 10, 20 or 30 mg in controlling IGF-1 and GH levels
Time frame: Interval between doses after titration in part 2 of treatment (injections 3-6)
Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.
Time frame: 1 dose interval after the last administration of Lanreotide Autogel 120mg
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 22 Nov 2019.
- Results publication: PubMed 21086246Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plockinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel(R) 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR. Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):156-62. doi: 10.1055/s-0030-1267244. Epub 2010 Nov 17.
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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?
A Phase 3 study testing lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval in people with Acromegaly, run by Ipsen at 1 site in Germany.
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 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 22 Nov 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels. (time frame: 1 dose interval after the last administration of Lanreotide Autogel 120mg). 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 NCT00444873, 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 22 Nov 2019.