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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
Klinikum Innenstadt
Munich, Germany
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
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
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