Status:
COMPLETED
Somatuline Autogel: Acromegaly Self/Partner Injection Study
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00149188
Start Date
February 1 2004
End Date
August 24 2005
Last Update
August 5 2019
Active Locations (10)
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1
Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
Hull, East Yorkshire, United Kingdom, HU3 2JZ
2
Department of Endocrinology, The Royal Free Hospital
Hampstead, London, United Kingdom, NW3 2QG
3
Dept of Endocrinology, Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
4
Department of Medicine, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH