Somatuline Autogel: Acromegaly Self/Partner Injection Study
- Conditions
- Acromegaly
- Registration Number
- NCT00149188
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- The patient must have a clinical diagnosis of acromegaly
- The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
- The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
- The patient must be able to store study medication in a refrigerator in their own home
- The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
- The patient has received pituitary radiotherapy within one year prior to screening
- The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
- The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (10)
Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
🇬🇧Hull, East Yorkshire, United Kingdom
Department of Endocrinology, The Royal Free Hospital
🇬🇧Hampstead, London, United Kingdom
Dept of Endocrinology, Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Department of Medicine, Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Department of Endocrinology, Coventry & Warwickshire Hospital
🇬🇧Coventry, United Kingdom
Department of Endocrinology, Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Department of Endocrinology, Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
🇬🇧Oxford, United Kingdom
Department of Endocrinology, Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Department of Endocrinology, Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom