NCT00234572

Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Lanreotide (Autogel formulation)

Timeline

• Start date: 2000-05-01
• Primary completion: 2003-01-03
• Completion: 2003-01-03
• First posted: 2005-10-07
• Last updated: 2019-08-02

Locations

29 sites across 8 countries: United States, Czechia, France, Germany, Hong Kong, Hungary, Netherlands, United Kingdom