Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216398
• Other study ID #: A-9B-52030-159
• Status: Completed
• Phase: Phase 4
• Start date: June 2004
• Est. completion date: June 22, 2006

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 22, 2006
• Est. primary completion date: June 22, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Lanreotide (Autogel formulation)

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.
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.
Secondary	The percentage of patients with normalised IGF-1 compared to the baseline visit.
Secondary	Change in the GH values compared to the baseline (Week 0) visit.
Secondary	Change in the IGF-1 values compared to the baseline (Week 0) visit.
Secondary	Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Secondary	Change in the serum octreotide levels compared to the baseline visit.
Secondary	Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Secondary	Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.