drugset / Trial / NCT02493517

Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly

NCT02493517 ↗

Phase 3 Completed 128 enrolled Ipsen
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.

Timeline

Start
2014-10
Primary completion
2016-11
Completion
2017-02-16

Outcome

Met primary endpoint

paper Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was - 0.32 (- 0.74, 0.11; per protocol population) PMID 32366244 ↗

paper CONCLUSIONS: Lanreotide autogel was non-inferior to lanreotide 40 mg PR in Chinese patients with active acromegaly after 32 weeks of treatment. PMID 32366244 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanreotide Other / unclassified 40 mg Subcutaneous
Subject Lanreotide Other / unclassified 60 mg Subcutaneous
Subject Lanreotide Other / unclassified 90 mg Subcutaneous
Subject Lanreotide Other / unclassified 120 mg Subcutaneous

Indications