Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 28 day dose interval<br> | Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval<br>* Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.<br>|
| Experimental: 42 day dose interval<br> | Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval<br>* Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.<br>|
| Experimental: 56 day dose interval<br> | Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval<br>* Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 1 dose interval after the last administration of Lanreotide Autogel 120mg | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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 |  | 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. |  | 1 dose interval after the last administration of Lanreotide Autogel 120mg | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)