Somatuline Autogel: Acromegaly Self/Partner Injection Study
The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.|
- To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
- To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
- To assess patient/partner and healthcare professional experience with unsupervised injections.
- To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.
|Study Start Date:||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149188
|Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary|
|Hull, East Yorkshire, United Kingdom, HU3 2JZ|
|Department of Endocrinology, The Royal Free Hospital|
|Hampstead, London, United Kingdom, NW3 2QG|
|Dept of Endocrinology, Aberdeen Royal Infirmary|
|Aberdeen, United Kingdom, AB25 2ZN|
|Department of Medicine, Queen Elizabeth Hospital|
|Birmingham, United Kingdom, B15 2TH|
|Department of Endocrinology, Coventry & Warwickshire Hospital|
|Coventry, United Kingdom, CV1 4FH|
|Department of Endocrinology, Leicester Royal Infirmary|
|Leicester, United Kingdom, LE1 5WW|
|Department of Endocrinology, Manchester Royal Infirmary|
|Manchester, United Kingdom, M13 9WL|
|The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital|
|Oxford, United Kingdom, OX3 7LJ|
|Department of Endocrinology, Royal Hallamshire Hospital|
|Sheffield, United Kingdom, S10 2JF|
|Department of Endocrinology, Sunderland Royal Hospital|
|Sunderland, United Kingdom, SR4 7TP|
|Study Director:||UK Medical Director, MD||Ipsen|