Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Phase 4

Completed

• Conditions: Acromegaly

• Registration Number: NCT00216398
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2006-06-22
• Study Completion: 2006-06-22
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in the GH 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.
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Change in serum lanreotide levels 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.
The percentage of patients with normalised IGF-1 compared to the baseline visit.

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia