DRUG
Somatuline Autogel: Acromegaly Self/Partner Injection Study
Status
Completed
Phase
Phase 4
Enrollment
30
Locations
10
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 8, 2005
Study start
Feb 2004
Primary completion
Aug 24, 2005
Study completion
Aug 24, 2005
Results posted
Not reported
Registry updated
Aug 5, 2019
Outcomes
What the study measures.
Primary outcomes
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
Secondary outcomes
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 locations
10 registered sites.
United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
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, Royal Hallamshire Hospital
Sheffield, United Kingdom
Department of Endocrinology, Sunderland Royal Hospital
Sunderland, United Kingdom
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