Non Interventional Post Marketing Programme in Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Non Interventional Post Marketing Programme in Acromegaly

Official Title

An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals.

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

Study Type

Observational

Primary Outcome

safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional

Secondary Outcome

 efficacy of Somatuline Autogel in both groups

Condition

Acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

42

Start Date

July 2008

Completion Date

March 2013

Primary Completion Date

September 2012

Eligibility Criteria

        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).

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT00747500

Organization ID

Y-97-52030-213

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

January 2019