The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
A Phase IV, Multicentre, Open-Label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
Secondary Outcome Measures:
- The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
- The percentage of patients with normalised IGF-1 compared to the baseline visit.
- Change in the GH values compared to the baseline (Week 0) visit.
- Change in the IGF-1 values compared to the baseline (Week 0) visit.
- Change in serum lanreotide levels compared to the baseline (Week 0) visit.
- Change in the serum octreotide levels compared to the baseline visit.
- Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
- Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
June 2004; Study completion: June 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- Clinical diagnosis of acromegaly
- The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
- The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
- Life expectancy of at least 2 years
- Adenectomy within past 6 months, or likely during study period
- Radiotherapy for acromegalic disease within 1 year, or likely during study period
- Unstable concomitant dopamine agonist therapy
Westmead Hospital, Westmead, New South Wales, 2145, Australia
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