Status:
COMPLETED
Non Interventional Post Marketing Programme in Acromegaly
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the sa...
Eligibility Criteria
Inclusion
- The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis.
- The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
- The patient must have a diagnosis of acromegaly.
- The patient must be at least 18 years of age.
- For patients receiving or intending to receive Somatuline Autogel by home injection:
- The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service.
Exclusion
- The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00747500
Start Date
July 1 2008
End Date
March 1 2013
Last Update
January 7 2019
Active Locations (7)
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1
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
2
Barnsley General Hospital
Barnsley, United Kingdom
3
University Hospital Coventry & Warwickshire
Coventry, United Kingdom
4
Leeds General Infirmary
Leeds, United Kingdom