NCT00444873

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval	Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-03-08
• Last updated: 2019-11-22

Locations

1 site across 1 country: Germany