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Lanreotide Autogel in acromegaly after octreotide LAR

NCT00216398Phase 4

Key facts

Status: Completed
Start: Jun 2004
Primary completion: Jun 2006
Countries: 1
Sponsor: Ipsen
Modality: Peptides

Drugs: lanreotide
Conditions: acromegaly

Overview

Phase 4, open-label, single-arm trial of lanreotide in acromegaly, sponsored by Ipsen. Primary endpoint: 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. Started Jun 2004; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Single Group
All patients receive Lanreotide Autogel after switching from octreotide LAR.

Who it enrols

Patients with a clinical diagnosis of acromegaly, previously treated with a stable dose of octreotide LAR for at least four months. Patients must have a GH level <10 mU/L at screening. Excludes patients with recent adenectomy (within 6 months) or radiotherapy (within 1 year), or those on unstable concomitant dopamine agonist therapy.

Endpoints

Primary

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.44 weeks

Secondary

The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.44 weeks
The percentage of patients with normalised IGF-1 compared to the baseline visit.44 weeks
Change in the GH values compared to the baseline (Week 0) visit.44 weeks
Change in the IGF-1 values compared to the baseline (Week 0) visit.44 weeks
Change in serum lanreotide levels compared to the baseline (Week 0) visit.44 weeks
Change in the serum octreotide levels compared to the baseline visit.44 weeks
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.

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