Non Interventional Post Marketing Programme in Acromegaly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-03-31

Brief Summary

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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 safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").

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Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No