Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

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.

Official Title

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

Conditions

Acromegaly

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

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.

Study Start

June 2004; Study completion: June 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Total Enrolment

8

Contact Details

Westmead Hospital, Westmead, New South Wales, 2145, Australia

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