- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444873
Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
November 21, 2019 updated by: Ipsen
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Munich, Germany, 80336
- Klinikum Innenstadt
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 28 day dose interval
|
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
|
Experimental: 42 day dose interval
|
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
|
Experimental: 56 day dose interval
|
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 dose interval after the last administration of Lanreotide Autogel 120mg
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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)
|
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
|
1 dose interval after the last administration of Lanreotide Autogel 120mg
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
March 7, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Actual)
November 22, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-94-52030-163
- 2004-001435-33 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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