Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00216398

Enrollment

Registered

2005-09-22

Start date

2004-06-30

Completion date

2006-06-22

Last updated

2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

acromegaly, growth hormone

Brief summary

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.

Interventions

DRUGLanreotide (Autogel formulation)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 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.	—
Change in serum lanreotide levels compared to the baseline (Week 0) visit.	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026