Brief Title
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
Condition
Acromegaly
Intervention
Lanreotide (Autogel formulation)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
June 2004
Completion Date
June 22, 2006
Primary Completion Date
June 22, 2006
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Study Director, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00216398
Organization ID
A-9B-52030-159
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Study Director, Study Director, Ipsen
Verification Date
August 2019